NCT07600008 Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
| NCT ID | NCT07600008 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University Hospital Olomouc |
| Condition | Reflux Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-01-15 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux. The objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms. Patients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur. Oral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07600008 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 55 Years, studying Reflux Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07600008 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07600008 currently recruiting?
Yes, NCT07600008 is actively recruiting participants. Contact the research team at vit.navratil@fnol.cz for enrollment information.
Where is the NCT07600008 trial being conducted?
This trial is being conducted at Olomouc, Czechia.
Who is sponsoring the NCT07600008 clinical trial?
NCT07600008 is sponsored by University Hospital Olomouc. The trial plans to enroll 50 participants.