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A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
Lactobacillus rhamnosus GG
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).
  • Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
  • Only those with an absence of symptoms will eligible to participate.

Exclusion Criteria:

  • For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
  • Chronic daily use of medications affecting GI secretion or motor function.
  • The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
  • Pregnancy.

Sites / Locations

  • Mayo Clinic ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus rhamnosus GG Group

Placebo Group

Arm Description

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Outcomes

Primary Outcome Measures

Change in Observed Operational Taxonomic Unit (OTU) diversity.
Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.

Secondary Outcome Measures

Adverse Events
Number of participants to report adverse events.
Changes in Shannon diversity index.
Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.
Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.
Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups.
Changes in taxa units.
Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.

Full Information

First Posted
August 24, 2022
Last Updated
March 7, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05517928
Brief Title
A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Official Title
Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus rhamnosus GG Group
Arm Type
Experimental
Arm Description
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
40 MG oral capsules daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus GG
Intervention Description
Given as Culturelle Digestive Probiotic in the form of oral capsules daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsules daily that look exactly like the study drug, but contains to active ingredient
Primary Outcome Measure Information:
Title
Change in Observed Operational Taxonomic Unit (OTU) diversity.
Description
Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.
Time Frame
Baseline, Day 56
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants to report adverse events.
Time Frame
60 days
Title
Changes in Shannon diversity index.
Description
Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.
Time Frame
Baseline, Day 56
Title
Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.
Description
Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups.
Time Frame
Baseline, Day 56
Title
Changes in taxa units.
Description
Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.
Time Frame
Baseline, Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.). Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire. Only those with an absence of symptoms will eligible to participate. Exclusion Criteria: For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy). Chronic daily use of medications affecting GI secretion or motor function. The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease. Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonas Berhe, B.S
Phone
4803016315
Email
berhe.yonas@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John DiBaise, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonas Berhe, B.S
Phone
480-301-6315
Email
berhe.yonas@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

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