Gastric Acid Suppression and Probiotic Colonization

NCT03327051 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 41681
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Probiotics

Outcome Measures

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.

  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 Outcomes (4)

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

  Week 0 through Week 4

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

  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).

  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).

  Week 0 and Week 4

Study Arms (2)

Omeprazole and VSL #3

ACTIVE COMPARATOR

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

Drug: Omeprazole; Dietary Supplement: VSL #3

Placebo and VSL #3

PLACEBO COMPARATOR

Participants will receive placebo and VSL #3 Probiotics

Dietary Supplement: VSL #3; Drug: Placebo

Interventions

Omeprazole DRUG

Proton pump inhibitor (PPI) that suppresses gastric acid secretion

Omeprazole and VSL #3

VSL #3 DIETARY_SUPPLEMENT

Probiotics

Omeprazole and VSL #3; Placebo and VSL #3

Placebo DRUG

Placebo to match omeprazole

Placebo and VSL #3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Singh G, Haileselassie Y, Briscoe L, Bai L, Patel A, Sanjines E, Hendler S, Singh PK, Garud NR, Limketkai BN, Habtezion A. The effect of gastric acid suppression on probiotic colonization in a double blinded randomized clinical trial. Clin Nutr ESPEN. 2022 Feb;47:70-77. doi: 10.1016/j.clnesp.2021.11.005. Epub 2021 Nov 10.

  PMID: 35063245 DERIVED

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Aida Habtezion
• Organization: Stanford University

aidah@stanford.edu

650-736-5555

Study Officials

• Aida Habtezion, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Gastroenterology and Hepatology)

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 31, 2017
• Study Start: March 20, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 11, 2020
• Results First Posted: January 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)