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

Healthy Clinical Trial

Official title:

Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517928
• Other study ID #: 21-007621
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Yonas Berhe, B.S
• Phone: 4803016315
• Email: berhe.yonas[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Healthy

Intervention

Drug:
• Omeprazole
40 MG oral capsules daily

Dietary Supplement:
• Lactobacillus rhamnosus GG
Given as Culturelle Digestive Probiotic in the form of oral capsules daily

Drug:
• Placebo
Oral capsules daily that look exactly like the study drug, but contains to active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 56
Secondary	Adverse Events	Number of participants to report adverse events.	60 days
Secondary	Changes in Shannon diversity index.	Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.	Baseline, Day 56
Secondary	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.	Baseline, Day 56
Secondary	Changes in taxa units.	Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.	Baseline, Day 56