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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Omeprazole
* Dietary Supplement: Lactobacillus rhamnosus GG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus rhamnosus GG Group<br>Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal. | Drug: Omeprazole<br>* 40 MG oral capsules daily<br>Dietary Supplement: Lactobacillus rhamnosus GG<br>* Given as Culturelle Digestive Probiotic in the form of oral capsules daily<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal. | Drug: Omeprazole<br>* 40 MG oral capsules daily<br>Drug: Placebo<br>* Oral capsules daily that look exactly like the study drug, but contains to active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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