Evaluating the effects of Lactobacillus rhamnosus GG on gut health in people taking proton pump inhibitors
Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
This study tests if taking the probiotic Lactobacillus rhamnosus GG can help improve gut health in people who are also taking a common acid reflux medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT05517928 on ClinicalTrials.gov |
What this trial studies
This study investigates how the probiotic Lactobacillus rhamnosus GG affects the gut microbiome changes caused by proton pump inhibitors (PPIs), which are commonly used to treat acid reflux. Participants will be healthy individuals who are not experiencing gastrointestinal symptoms and will be given either the probiotic, a PPI (omeprazole), or a placebo. The study aims to assess the impact of these interventions on the microbial composition in the gastrointestinal tract. The research will help understand the relationship between PPIs and gut health.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals who are not experiencing any gastrointestinal symptoms and are on a regular unrestricted diet.
Not a fit: Patients with chronic gastrointestinal issues, those on medications affecting GI function, or individuals with untreated psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how probiotics can mitigate the negative effects of PPIs on gut microbiota, potentially improving gastrointestinal health for patients on these medications.
How similar studies have performed: While there is ongoing research into probiotics and gut health, this specific approach to evaluating Lactobacillus rhamnosus GG in the context of PPI-induced dysbiosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: John DiBaise, MD — Mayo Clinic
- Study coordinator: Alexandria Ramirez
- Email: ramirez.alexandria@mayo.edu
- Phone: 4805741853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.