Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A probiotic dietary supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Reflux Disease, Microbiome, Probiotics Supplement. Basic parameters: 40 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement Placebo
placebo with the same appearance as the probiotic supplement
Primary outcome measures
- Change of % of patients with dysbiosis in the gastrointestinal tract caused by the disease itself and/or pharmacotherapy - as assessed by using whole-genome sequencing [Time frame: From enrollment to the end of supplementation at 6 weeks]
Secondary outcome measures (2)
- Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires [Time frame: From enrollment to the end of supplementation at 6 weeks]
- Evaluation of safety and tolerability of the preparation - prevalence of patient-reported adverse events as recorded in questionnaires [Time frame: From enrollment to the end of supplementation at 6 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Czechia · 1 center
- University Hospital Olomouc — Olomouc
Identifiers
NCT: NCT07600008 · FW10010127