Gastric Acid Suppression and Probiotic Colonization (PR)

Stanford University

Status and phase: Completed; Phase 4

Conditions: Probiotics

Treatments: Dietary Supplement: VSL #3; Drug: Omeprazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03327051

41681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Omeprazole and VSL #3

Active Comparator group

Description:

Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics

Treatment:

Dietary Supplement: VSL #3

Drug: Omeprazole

Placebo and VSL #3

Placebo Comparator group

Description:

Participants will receive placebo and VSL #3 Probiotics

Treatment:

Drug: Placebo

Dietary Supplement: VSL #3