Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux

May 17, 2026 updated by: University Hospital Olomouc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Olomouc, Czechia, 77900
        • Recruiting
        • University Hospital Olomouc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Dietary supplement: Placebo
placebo with the same appearance as the probiotic supplement
Active Comparator: Probiotic supplement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of supplementation at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
From enrollment to the end of supplementation at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Collaborators

Masaryk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FW10010127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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