Gastric Acid Suppression and Probiotic Colonization

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-12-30

Brief Summary

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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.

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Detailed Description

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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

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Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omeprazole and VSL #3

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

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

Proton pump inhibitor (PPI) that suppresses gastric acid secretion

VSL #3

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Placebo and VSL #3

Participants will receive placebo and VSL #3 Probiotics

Group Type PLACEBO_COMPARATOR

VSL #3

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Placebo

Intervention Type DRUG

Placebo to match omeprazole

Interventions

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Omeprazole

Proton pump inhibitor (PPI) that suppresses gastric acid secretion

Intervention Type DRUG

VSL #3

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo to match omeprazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes