Healthy
Conditions
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.
Interventions
DRUGOmeprazole
40 MG oral capsules daily
DIETARY_SUPPLEMENTLactobacillus rhamnosus GG
Given as Culturelle Digestive Probiotic in the form of oral capsules daily
DRUGPlacebo
Oral capsules daily that look exactly like the study drug, but contains to active ingredient
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Observed Operational Taxonomic Unit (OTU) diversity. | Baseline, Day 56 | Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 60 days | Number of participants to report adverse events. |
| Changes in Shannon diversity index. | Baseline, Day 56 | 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. | Baseline, Day 56 | Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups. |
| Changes in taxa units. | Baseline, Day 56 | Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups. |
Countries
United States
Contacts
Primary ContactAlexandria Ramirez
Outcome results
None listed