Phase 4
N=39
Gastric Acid Suppression and Probiotic Colonization
Probiotics
Bottom Line
View on ClinicalTrials.gov: NCT03327051 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: 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; 0.8186 percentage of abundance — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omeprazole (Drug); VSL #3 (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 0.8186 | 0.04 sig |
| SECONDARY Number of Participants With Symptoms Related to VSL#3 Treatment. |
0; 2; 2; 0; 2; 0 | — |
| SECONDARY Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration |
66.4; 65.6; 66.2; 68.1; 25.6; 27.2 | — |
| SECONDARY Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3). |
80809.5; 286707.9 | — |
| SECONDARY Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group). |
95819.8; 4726.2; 539032.9; 249632.3; 87765.6; 22405.5 | — |
Summary
Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers ages 18 years and ≤ 75 years.
- Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.
Exclusion Criteria
- Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
- Previous abdominal surgery
- Currently pregnant or nursing
- Had H. Pylori Infection
- Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
- Currently consuming herbs or probiotics
Data sourced from ClinicalTrials.gov (NCT03327051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.