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OpenTrials
Completed

NCT Number: NCT03327051

Gastric Acid Suppression and Probiotic Colonization

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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Key information

Conditions

Probiotics

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

Proton pump inhibitor (PPI) that suppresses gastric acid secretion

VSL #3

Dietary Supplement

Probiotics

Placebo

Drug

Placebo to match omeprazole

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Number of Participants With Symptoms Related to VSL#3 Treatment.

    Time frame: Week 0 through Week 4

    Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.

  2. Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration

    Time frame: 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.

  3. Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).

    Time frame: 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.

  4. Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

The Effect of Gastric Acid Suppression on Probiotic Colonization

Acronym: PR

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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