MedTrace Logo

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

NCT07600008 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Reflux Disease
  • Microbiome
  • Probiotics Supplement

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

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER

  • University Hospital Olomouc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-05-30
Completion
2026-07-30

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600008 on ClinicalTrials.gov