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

NCT07600008 | Recruiting Early Phase 1

• 1 other identifier: FW10010127
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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

  From enrollment to the end of supplementation at 6 weeks

Secondary Outcomes (2)

• Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires

  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

  From enrollment to the end of supplementation at 6 weeks

Study Arms (2)

Probiotic supplement

ACTIVE COMPARATOR

Dietary Supplement: A probiotic dietary supplement

Placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

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.

Probiotic supplement

Placebo DIETARY_SUPPLEMENT

placebo with the same appearance as the probiotic supplement

Placebo group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed GERD.
• Stable health without current complications.
• Patients on stable pharmacological PPI therapy (rabeprazole).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Masaryk University: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Vít Navrátil, MUDr, Ph.D.

CONTACT

+420588445308; vit.navratil@fnol.cz

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: May 20, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CZ (1)