Trial Outcomes & Findings for Gastric Acid Suppression and Probiotic Colonization (NCT NCT03327051)
NCT ID: NCT03327051
Last Updated: 2020-03-11
Results Overview
Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.
COMPLETED
PHASE4
39 participants
Week 4
2020-03-11
Participant Flow
Participants attended an initial study visit at week -2, followed by a baseline visit at week 0, and a final visit at week 4.
Participant milestones
| Measure |
Omeprazole and VSL #3
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
Received Treatment
|
16
|
16
|
|
Overall Study
Attended Visit 2 (Week 0)
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastric Acid Suppression and Probiotic Colonization
Baseline characteristics by cohort
| Measure |
Omeprazole and VSL #3
n=15 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
n=15 Participants
Placebo and VSL #3 Probiotics
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 13 • n=5 Participants
|
37 years
STANDARD_DEVIATION 12 • n=7 Participants
|
37 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic / White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic / Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic / Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic / Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic / Native Hawaiian / Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Relative Abundance of Probiotic Strains
|
0.3653 percentage of abundance
STANDARD_DEVIATION 0.407 • n=5 Participants
|
0.5875 percentage of abundance
STANDARD_DEVIATION 0.5691 • n=7 Participants
|
0.4764 percentage of abundance
STANDARD_DEVIATION 0.4907 • n=5 Participants
|
|
Number of participants experiencing gastro-intestinal symptoms.
Bloating
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of participants experiencing gastro-intestinal symptoms.
Flatulence
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of participants experiencing gastro-intestinal symptoms.
Diarrhea
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Participants who attended the week 4 visit are included in the analysis.
Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.
Outcome measures
| Measure |
Omeprazole and VSL #3
n=14 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
n=15 Participants
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.
|
1.002 percentage of abundance
Standard Deviation 0.8403
|
0.8186 percentage of abundance
Standard Deviation 0.5234
|
SECONDARY outcome
Timeframe: Week 0 through Week 4Population: Participants who attended the week 4 visit are included in the analysis.
Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.
Outcome measures
| Measure |
Omeprazole and VSL #3
n=14 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
n=15 Participants
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Number of Participants With Symptoms Related to VSL#3 Treatment.
Bloating
|
0 Participants
|
2 Participants
|
|
Number of Participants With Symptoms Related to VSL#3 Treatment.
Flatulence
|
2 Participants
|
0 Participants
|
|
Number of Participants With Symptoms Related to VSL#3 Treatment.
Diarrhea
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 4Population: Participants who attended the week 4 visit are included in the analysis.
From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed.
Outcome measures
| Measure |
Omeprazole and VSL #3
n=14 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
n=15 Participants
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Bacteroidetes at Week 0
|
66.4 percentage of abundance
Standard Deviation 15.1
|
65.6 percentage of abundance
Standard Deviation 11.3
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Bacteroidetes at Week 4
|
66.2 percentage of abundance
Standard Deviation 15.0
|
68.1 percentage of abundance
Standard Deviation 10.2
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Firmicutes at Week 0
|
25.6 percentage of abundance
Standard Deviation 9.6
|
27.2 percentage of abundance
Standard Deviation 9.6
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Firmicutes at Week 4
|
25.7 percentage of abundance
Standard Deviation 12.6
|
25.0 percentage of abundance
Standard Deviation 8.3
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Proteobacteria at Week 0
|
4.1 percentage of abundance
Standard Deviation 6.0
|
2.7 percentage of abundance
Standard Deviation 1.8
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Proteobacteria at Week 4
|
3.12 percentage of abundance
Standard Deviation 3.7
|
2.7 percentage of abundance
Standard Deviation 2.4
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Actinobacteria at Week 0
|
2.5 percentage of abundance
Standard Deviation 2.5
|
3.2 percentage of abundance
Standard Deviation 2.8
|
|
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Actinobacteria at Week 4
|
3.7 percentage of abundance
Standard Deviation 3.7
|
3.2 percentage of abundance
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Week 0 and Week 4Population: Participants in the Omeprazole and VSL#3 group who attended the week 4 visit are included in the analysis.
From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only.
Outcome measures
| Measure |
Omeprazole and VSL #3
n=14 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).
1H-Indole-4-carbaldehyde at Week 0
|
80809.5 MZ/RT
Standard Deviation 118044.6
|
—
|
|
Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).
1H-Indole-4-carbaldehyde at Week 4
|
286707.9 MZ/RT
Standard Deviation 567693.1
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 4Population: Participants in the Placebo and VSL#3 group who attended the week 4 visit are included in the analysis.
From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only.
Outcome measures
| Measure |
Omeprazole and VSL #3
n=15 Participants
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
11-OXOURSOLIC ACID ACETATE at Week 0
|
95819.8 MZ/RT
Standard Deviation 146506.5
|
—
|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
11-OXOURSOLIC ACID ACETATE at Week 4
|
4726.2 MZ/RT
Standard Deviation 18243.3
|
—
|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
FA(14:0) at Week 0
|
539032.9 MZ/RT
Standard Deviation 519162.2
|
—
|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
FA(14:0) at Week 4
|
249632.3 MZ/RT
Standard Deviation 219622.8
|
—
|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
Iloprost S-isomer at Week 0
|
87765.6 MZ/RT
Standard Deviation 189360.0
|
—
|
|
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
Iloprost S-isomer at Week 4
|
22405.5 MZ/RT
Standard Deviation 63899.1
|
—
|
Adverse Events
Omeprazole and VSL #3
Placebo and VSL #3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omeprazole and VSL #3
n=19 participants at risk
Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
|
Placebo and VSL #3
n=20 participants at risk
Placebo and VSL #3 Probiotics
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
0.00%
0/20 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 3 • 6 weeks
|
10.0%
2/20 • Number of events 2 • 6 weeks
|
|
Gastrointestinal disorders
Increased stool frequency
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
0.00%
0/20 • 6 weeks
|
|
Gastrointestinal disorders
Bloating
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
20.0%
4/20 • Number of events 7 • 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
10.5%
2/19 • Number of events 2 • 6 weeks
|
5.0%
1/20 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
5.0%
1/20 • Number of events 1 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/19 • 6 weeks
|
5.0%
1/20 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place