Gastric Acid Suppression and Probiotic Colonization

Study Overview
=================
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.

Official Title
-----------------
The Effect of Gastric Acid Suppression on Probiotic Colonization

Conditions
-----------------
Probiotics

Intervention / Treatment
-----------------
* Drug: Omeprazole
* Dietary Supplement: VSL #3
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole and VSL #3<br>Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics | Drug: Omeprazole<br>* Proton pump inhibitor (PPI) that suppresses gastric acid secretion<br>Dietary Supplement: VSL #3<br>* Probiotics<br>|
| Placebo Comparator: Placebo and VSL #3<br>Participants will receive placebo and VSL #3 Probiotics | Dietary Supplement: VSL #3<br>* Probiotics<br>Drug: Placebo<br>* Placebo to match omeprazole<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 4 | 

Secondary Outcome Measures

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