NCT03327051

Gastric Acid Suppression and Probiotic Colonization

The Effect of Gastric Acid Suppression on Probiotic Colonization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Probiotics

Interventions

Type	Name	Description
DRUG	Omeprazole	Proton pump inhibitor (PPI) that suppresses gastric acid secretion
DIETARY_SUPPLEMENT	VSL #3	Probiotics
DRUG	Placebo	Placebo to match omeprazole

Timeline

• Start date: 2018-03-20
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2017-10-31
• Last updated: 2020-03-11
• Results posted: 2020-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study