Trial Outcomes & Findings for Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber) (NCT NCT04209075)
NCT ID: NCT04209075
Last Updated: 2022-08-30
Results Overview
A composite tolerability score based on 4 GI side effect profile categories (stool consistency, urgency to evacuate, bloating sensation, and flatulence), assessed by daily survey, will be calculated using a principal components analysis. A scale range of GI tolerability score is (1.14, 3.3). A higher tolerability score indicates a lower side effect profile
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
1 week (assessed daily for 7 days)
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
Placebo Then Prebiotic
Participant will take Placebo during Period 1 and Prebiotic during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Prebiotic Then Placebo
Participant will take Prebiotic during Period 1 and Placebo during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Baseline characteristics by cohort
| Measure |
Placebo Then Prebiotic
n=4 Participants
Participant will take Placebo during Period 1 and Prebiotic during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Prebiotic Then Placebo
n=2 Participants
Participant will take Prebiotic during Period 1 and Placebo during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.5 years
STANDARD_DEVIATION 0.58 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 3.54 • n=7 Participants
|
17.2 years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index
|
42.29 kg/m^2
STANDARD_DEVIATION 10.9 • n=5 Participants
|
39.41 kg/m^2
STANDARD_DEVIATION 2.4 • n=7 Participants
|
41.33 kg/m^2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Systolic Blood Pressure
|
130.5 mmHg
STANDARD_DEVIATION 8.3 • n=5 Participants
|
116.5 mmHg
STANDARD_DEVIATION 17.7 • n=7 Participants
|
125.8 mmHg
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Diastolic Blood Pressure
|
72.5 mmHg
STANDARD_DEVIATION 3.0 • n=5 Participants
|
64.5 mmHg
STANDARD_DEVIATION 3.5 • n=7 Participants
|
69.8 mmHg
STANDARD_DEVIATION 5.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week (assessed daily for 7 days)A composite tolerability score based on 4 GI side effect profile categories (stool consistency, urgency to evacuate, bloating sensation, and flatulence), assessed by daily survey, will be calculated using a principal components analysis. A scale range of GI tolerability score is (1.14, 3.3). A higher tolerability score indicates a lower side effect profile
Outcome measures
| Measure |
Placebo Then Prebiotic
n=4 Participants
Participant will take Placebo during Period 1 and Prebiotic during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Prebiotic Then Placebo
n=2 Participants
Participant will take Prebiotic during Period 1 and Placebo during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
|---|---|---|
|
Gastrointestinal (GI) Tolerability Score
Period 1
|
2.31 score on a scale
Standard Deviation 0.62
|
2.63 score on a scale
Standard Deviation 0.33
|
|
Gastrointestinal (GI) Tolerability Score
Period 2
|
2.70 score on a scale
Standard Deviation 0.27
|
2.71 score on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 1 week and 4 weeksPopulation: SCFA analysis of stool samples was not and never will be conducted, data was not collected for this Outcome Measure.
Stool SCFA, including propionate and butyrate, will be measured in stool samples. SCFAs are microbial metabolites that are gut mediators of metabolism.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Then Prebiotic: Period 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Prebiotic Then Placebo: Period 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Then Prebiotic: Period 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Prebiotic Then Placebo: Period 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Then Prebiotic: Period 1
n=4 participants at risk
Participant will take Placebo during Period 1 and Prebiotic during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Prebiotic Then Placebo: Period 1
n=2 participants at risk
Participant will take Prebiotic during Period 1 and Placebo during Period 2
Biomebliss: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.
Metformin: Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
Placebo: Placebo Comparator
|
Placebo Then Prebiotic: Period 2
n=4 participants at risk
Participant will take Placebo during Period 1 and Prebiotic during Period 2
|
Prebiotic Then Placebo: Period 2
n=2 participants at risk
Participant will take Prebiotic during Period 1 and Placebo during Period 2
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/4 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
|
Endocrine disorders
Hypoglysemia
|
0.00%
0/4 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
0.00%
0/4 • 9 Weeks
|
50.0%
1/2 • Number of events 1 • 9 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
25.0%
1/4 • Number of events 1 • 9 Weeks
|
0.00%
0/2 • 9 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place