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Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
Sponsor: University Hospital Olomouc
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.
Key Details
Gender
All
Age Range
40 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-01-15
Completion Date
2026-07-30
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
A probiotic dietary supplement
A probiotic dietary supplement containing a blend of probiotic bacteria from the Lactobacillaceae family, and the genera Streptococcus and Bifidobacterium, selected based on the latest knowledge concerning the use of probiotics in relation to GERD.
Placebo
placebo with the same appearance as the probiotic supplement
Locations (1)
University Hospital Olomouc
Olomouc, Czechia