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NCT Number: NCT07600008

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

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.

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Key information

Conditions

Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Microbiome Probiotics Supplement

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

Location status: Recruiting

Location contact

Vít Navrátil, MUDr, Ph.D.

CONTACT

[email protected]

+420588445308

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A probiotic dietary supplement

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

Dietary Supplement

placebo with the same appearance as the probiotic supplement

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Vít Navrátil, MUDr, Ph.D.

CONTACT

[email protected]

+420588445308

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Masaryk University

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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