Health TrialsbyHealthPanel

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

ConditionsReflux DiseaseMicrobiomeProbiotics Supplement
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-55
SponsorUniversity Hospital Olomouc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed GERD.

Stable health without current complications.

Patients on stable pharmacological PPI therapy (rabeprazole).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Probiotic supplementActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Olomouc

Lead sponsor

Masaryk University

Collaborator

Source ClinicalTrials.gov
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