Actively Recruiting
Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
Led by University Hospital Olomouc · Updated on 2026-05-20
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University Hospital Olomouc
Lead Sponsor
M
Masaryk University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a probiotic dietary supplement as supportive treatment for patients diagnosed with gastroesophageal reflux disease (GERD) who are currently on proton pump inhibitor (PPI) therapy. This early phase 1, two-arm, double-blind, randomized, placebo-controlled study aims to assess how the probiotic affects the diversity and composition of the gut microbiome. The study also monitors changes in the oral microbiome, patient quality of life, and GERD symptoms to better understand probiotic supplementation effects. Participants will take either the probiotic supplement or a placebo, both administered as 2 tablets twice daily—once in the morning before meals and once in the evening after meals—for six weeks. If any adverse effects occur, supplementation will be stopped. Oral and rectal swabs will be collected before and after the supplementation period to analyze microbiome changes. During the study, patients will regularly complete questionnaires to track their GERD symptoms and any adverse events. The primary outcome is the change in the percentage of patients with gastrointestinal dysbiosis caused by GERD or its treatment, measured from enrollment to the end of supplementation. Secondary outcomes include symptom changes assessed by standardized scores and evaluation of the safety and tolerability of the probiotic. Participation lasts for six weeks of supplementation with ongoing monitoring throughout.
CONDITIONS
Brief Title
Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed gastroesophageal reflux disease (GERD).
- Stable health without current complications.
- On stable pharmacological proton pump inhibitor (PPI) therapy, specifically rabeprazole.
- Aged between 40 and 55 years.
- All genders eligible.
You will not qualify if you...
- Use of probiotics or prebiotics within the last 4 weeks.
- Pregnant or breastfeeding.
- Received systemic antimicrobial therapy within the last 4 weeks.
- Infectious disease of the respiratory or gastrointestinal tract within the last 2 weeks.
- Serious chronic diseases affecting study results, including cancer, diabetes, inflammatory bowel disease, or diagnosed small intestinal bacterial overgrowth (SIBO).
- Prior surgeries such as fundoplication or resections of the esophagus or stomach.
- Psychiatric or cognitive disorders.
- Hypersensitivity to components of the investigational product.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either a probiotic dietary supplement or a placebo for supportive care of gastroesophageal reflux disease (GERD).
Visits occur at enrollment and periodically during supplementation
Trial Site Locations
Total: 1 location
1
University Hospital Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
Research Team
V
Vít Navrátil, MUDr, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here