Gastric Acid Suppression and Probiotic Colonization

Phase 4

Completed

Conditions: Probiotics

Interventions: Dietary Supplement: VSL #3
Drug: Omeprazole
Drug: Placebo

Registration Number: NCT03327051

Lead Sponsor: Stanford University

Brief 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.

Detailed Description: All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.

The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.

Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and VSL #3	Placebo	Participants will receive placebo and VSL #3 Probiotics
Placebo and VSL #3	VSL #3	Participants will receive placebo and VSL #3 Probiotics
Omeprazole and VSL #3	VSL #3	Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
Omeprazole and VSL #3	Omeprazole	Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics

Primary Outcome Measures

Name	Time	Method
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.	Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Symptoms Related to VSL#3 Treatment.	Week 0 through Week 4	Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).	Week 0 and Week 4	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.
Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).	Week 0 and Week 4	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.
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration	Week 0 and Week 4	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.