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

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка Placebo
  placebo with the same appearance as the probiotic supplement

Первичные конечные точки

• 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 [Срок оценки: From enrollment to the end of supplementation at 6 weeks]

Вторичные конечные точки (2)

• Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires [Срок оценки: 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 [Срок оценки: From enrollment to the end of supplementation at 6 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Чехия · 1 центр

• University Hospital Olomouc — Olomouc

Идентификаторы

NCT: NCT07600008 · FW10010127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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