Trial Outcomes & Findings for Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults (NCT NCT06068894)
NCT ID: NCT06068894
Last Updated: 2026-02-05
Results Overview
The overall Patient-Reported Outcomes Measurement Information System (PROMIS) score symptom (composite) was calculated as follows: Individual items from the GI questionnaire were grouped into seven symptom domains: abdominal pain, bloating, abdominal distension, flatulence, constipation, diarrhea, and nausea. Each item was rated on a 0-4 scale (0 = "never," 4 = "always"). For each participant at each visit (week 0 and week 4), a domain-specific symptom severity score was defined as the maximum item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Between week 0 (Baseline) and week 4
Results posted on
2026-02-05
Participant Flow
Sixty participants signed informed consent and enrolled in the study. Before the baseline visit (Week 0), 10 participants voluntarily withdrew consent, leaving 50 participants who completed the baseline assessment.
Participant milestones
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Baseline characteristics by cohort
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=17 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=17 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=16 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=25 Participants
|
17 Participants
n=26 Participants
|
16 Participants
n=51 Participants
|
50 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=25 Participants
|
15 Participants
n=26 Participants
|
13 Participants
n=51 Participants
|
41 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
8 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=51 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=25 Participants
|
15 Participants
n=26 Participants
|
14 Participants
n=51 Participants
|
45 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=25 Participants
|
4 Participants
n=26 Participants
|
4 Participants
n=51 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=25 Participants
|
10 Participants
n=26 Participants
|
11 Participants
n=51 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=25 Participants
|
17 Participants
n=26 Participants
|
16 Participants
n=51 Participants
|
50 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Between week 0 (Baseline) and week 4The overall Patient-Reported Outcomes Measurement Information System (PROMIS) score symptom (composite) was calculated as follows: Individual items from the GI questionnaire were grouped into seven symptom domains: abdominal pain, bloating, abdominal distension, flatulence, constipation, diarrhea, and nausea. Each item was rated on a 0-4 scale (0 = "never," 4 = "always"). For each participant at each visit (week 0 and week 4), a domain-specific symptom severity score was defined as the maximum item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Mean Composite PROMIS Maximum Scores
Baseline (Week 0)
|
4.3 score on a scale
Standard Deviation 2.5
|
5.0 score on a scale
Standard Deviation 2.3
|
3.0 score on a scale
Standard Deviation 2.0
|
|
Mean Composite PROMIS Maximum Scores
Week 4
|
4.4 score on a scale
Standard Deviation 1.6
|
3.1 score on a scale
Standard Deviation 1.0
|
4.6 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4The difference in relative abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia (pre and post intervention) as measured by whole genome sequencing of stool.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium longum
|
1.13 percent change
Standard Deviation 2.12
|
2.00 percent change
Standard Deviation 4.05
|
-0.23 percent change
Standard Deviation 0.67
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium bifidum
|
-0.03 percent change
Standard Deviation 0.16
|
0.51 percent change
Standard Deviation 1.40
|
0.04 percent change
Standard Deviation 0.08
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium adolescentis
|
2.01 percent change
Standard Deviation 3.91
|
4.96 percent change
Standard Deviation 7.85
|
-0.14 percent change
Standard Deviation 0.87
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium pseudocatenulatum
|
1.39 percent change
Standard Deviation 2.60
|
0.91 percent change
Standard Deviation 2.37
|
-0.42 percent change
Standard Deviation 1.17
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium dentium
|
0.01 percent change
Standard Deviation 0.01
|
0.01 percent change
Standard Deviation 0.02
|
0.00 percent change
Standard Deviation 0.00
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium catenulatum
|
0.24 percent change
Standard Deviation 0.48
|
0.08 percent change
Standard Deviation 0.11
|
-0.01 percent change
Standard Deviation 0.04
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium pseudolongum
|
0.00 percent change
Standard Deviation 0.00
|
0.00 percent change
Standard Deviation 0.00
|
0.00 percent change
Standard Deviation 0.00
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Akkermansia muciniphila
|
0.29 percent change
Standard Deviation 0.66
|
0.45 percent change
Standard Deviation 1.78
|
-0.23 percent change
Standard Deviation 0.89
|
|
Mean Percent Change in Relative Abundance of Beneficial Bacteria
Bifidobacterium breve
|
0.02 percent change
Standard Deviation 0.05
|
0.04 percent change
Standard Deviation 0.09
|
-0.01 percent change
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-1α Concentration
Baseline (Week 0)
|
1.11 pg/mL
Standard Deviation 4.00
|
0.17 pg/mL
Standard Deviation 0.52
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Interleukin-1α Concentration
Week 4
|
0.40 pg/mL
Standard Deviation 0.96
|
0.02 pg/mL
Standard Deviation 0.08
|
0.07 pg/mL
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-1ß Concentration
Baseline (Week 0)
|
0.43 pg/mL
Standard Deviation 1.25
|
0.15 pg/mL
Standard Deviation 0.59
|
0.57 pg/mL
Standard Deviation 1.44
|
|
Interleukin-1ß Concentration
Week 4
|
0.55 pg/mL
Standard Deviation 2.14
|
0.49 pg/mL
Standard Deviation 1.30
|
0.33 pg/mL
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-6 Concentration
Baseline (Week 0)
|
1.87 pg/mL
Standard Deviation 1.50
|
4.57 pg/mL
Standard Deviation 9.70
|
2.56 pg/mL
Standard Deviation 1.78
|
|
Interleukin-6 Concentration
Week 4
|
1.87 pg/mL
Standard Deviation 1.60
|
3.26 pg/mL
Standard Deviation 5.73
|
2.10 pg/mL
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-8 Concentration
Baseline (Week 0)
|
12.86 pg/mL
Standard Deviation 6.16
|
11.20 pg/mL
Standard Deviation 5.21
|
13.25 pg/mL
Standard Deviation 7.19
|
|
Interleukin-8 Concentration
Week 4
|
101.92 pg/mL
Standard Deviation 352.85
|
11.53 pg/mL
Standard Deviation 5.29
|
14.82 pg/mL
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-12 Concentration
Baseline (Week 0)
|
85.35 pg/mL
Standard Deviation 193.49
|
4.60 pg/mL
Standard Deviation 11.34
|
14.08 pg/mL
Standard Deviation 108.31
|
|
Interleukin-12 Concentration
Week 4
|
9.49 pg/mL
Standard Deviation 24.10
|
4.13 pg/mL
Standard Deviation 8.10
|
47.19 pg/mL
Standard Deviation 100.19
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-17 Concentration
Baseline (Week 0)
|
17.71 pg/mL
Standard Deviation 58.31
|
2.89 pg/mL
Standard Deviation 4.81
|
26.96 pg/mL
Standard Deviation 80.85
|
|
Interleukin-17 Concentration
Week 4
|
2.88 pg/mL
Standard Deviation 6.09
|
6.23 pg/mL
Standard Deviation 11.61
|
34.14 pg/mL
Standard Deviation 111.18
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interleukin-18 Concentration
Baseline (Week 0)
|
377.68 pg/mL
Standard Deviation 114.18
|
464.26 pg/mL
Standard Deviation 166.10
|
415.11 pg/mL
Standard Deviation 115.77
|
|
Interleukin-18 Concentration
Week 4
|
387.98 pg/mL
Standard Deviation 150.25
|
459.46 pg/mL
Standard Deviation 140.76
|
412.02 pg/mL
Standard Deviation 164.36
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Baseline (Week 0)
|
3.53 pg/mL
Standard Deviation 1.48
|
3.98 pg/mL
Standard Deviation 2.25
|
4.63 pg/mL
Standard Deviation 1.41
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Wek 4
|
3.68 pg/mL
Standard Deviation 1.86
|
4.32 pg/mL
Standard Deviation 2.47
|
4.82 pg/mL
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Interferon Gamma (IFNγ) Concentration
Baseline (Week 0)
|
3.37 pg/mL
Standard Deviation 3.27
|
4.04 pg/mL
Standard Deviation 3.21
|
5.50 pg/mL
Standard Deviation 3.49
|
|
Interferon Gamma (IFNγ) Concentration
Week 4
|
3.30 pg/mL
Standard Deviation 2.80
|
5.51 pg/mL
Standard Deviation 6.75
|
4.05 pg/mL
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Change in C-Reactive Protein Concentration
|
-0.21 mg/L
Standard Deviation 0.32
|
-0.28 mg/L
Standard Deviation 0.35
|
-0.03 mg/L
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Between week 0 (Baseline) and week 4Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.
Outcome measures
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=15 Participants
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=15 Participants
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=11 Participants
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Change in Zonulin Concentration
|
-11.42 ng/mL
Standard Deviation 18.45
|
2.15 ng/mL
Standard Deviation 21.45
|
6.06 ng/mL
Standard Deviation 19.99
|
Adverse Events
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Galacto-oligosaccharides (GOS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS)
n=17 participants at risk
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
"Humanized" galacto-oligosaccharides (hGOS): 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Galacto-oligosaccharides (GOS)
n=17 participants at risk
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
Galacto-oligosaccharides (GOS): 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
|
Placebo
n=16 participants at risk
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
Matching Placebo: 10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/17 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
0.00%
0/16 • From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
|
Additional Information
Sylvia Becker-Dreps, MD, MPH
University of North Carolina at Chapel Hill
Phone: 984-974-4662
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place