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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
40 MG oral capsules daily
Given as Culturelle Digestive Probiotic in the form of oral capsules daily
Oral capsules daily that look exactly like the study drug, but contains to active ingredient
Mayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGChange 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.
Time frame: Baseline, Day 56
Adverse Events
Number of participants to report adverse events.
Time frame: 60 days
Changes in Shannon diversity index.
Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.
Time frame: 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.
Time frame: Baseline, Day 56
Changes in taxa units.
Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.
Time frame: Baseline, Day 56
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