Probiotic support for GERD patients on PPI therapy
Official title: Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
Run by University Hospital Olomouc · NCT07600008 · Data updated 2026-11-12
A small, two-arm study tests a probiotic supplement versus placebo to see if it changes gut and oral microbes and improves GERD symptoms and quality of life for people on PPI therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 55 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital Olomouc Academic / other |
| Locations | 1 site (Olomouc) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | May 30, 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT07600008 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with GERD who are on stable PPI therapy and do not have recent probiotic use or the listed exclusion conditions.
✕Probably not a fit
Patients with contraindications to probiotics, recent antibiotic use, active infectious diseases, or significant chronic illnesses may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase, randomized, double-blind study compares a probiotic dietary supplement to a placebo in adults with GERD who are on stable PPI therapy. Participants take two tablets twice daily for six weeks, with adverse effects monitored and supplementation halted if needed. Researchers will assess gut and oral microbiome changes, GERD symptoms, and quality of life, using swabs and patient questionnaires collected before and after treatment. The trial uses a two-arm design and includes microbiome analyses to explore potential mechanistic effects. Recruitment is centered at University Hospital Olomouc, in collaboration with Masaryk University.
Why it matters
Potential benefit: If successful, the probiotic supplement could help modulate the gut microbiome and improve GERD-related symptoms and quality of life for patients on PPI therapy.
How similar studies have gone: Previous work in probiotics for GI conditions supports potential microbiome modulation, though results for GERD specifically are variable and this study explores a novel combination in this patient group.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed GERD. * Stable health without current complications. * Patients on stable pharmacological PPI therapy (rabeprazole). Exclusion Criteria: * Use of probiotics or prebiotics within the last 4 weeks. * Pregnancy or breastfeeding. * Systemic antimicrobial therapy within the last 4 weeks. * Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks. * Serious chronic disease that could affect study results, including cancer, diabetes, inflammatory bowel disease, diagnosed SIBO. * Prior surgeries, especially fundoplication and resections of the esophagus or stomach. * Patients with psychiatric or cognitive disorders. * Hypersensitivity to components of the investigational product.
Where it's running
-
University Hospital Olomouc
Olomouc, Czechia Recruiting
Study contacts
- Study coordinator: Vít Navrátil, MUDr, Ph.D.
- Email: vit.navratil@fnol.cz
- Phone: +420588445308
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.