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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 초기 1단계
연락처 및 위치
연구 연락처
- 이름: Vít Navrátil, MUDr, Ph.D.
- 전화번호: +420588445308
- 이메일: vit.navratil@fnol.cz
연구 장소
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Olomouc, 체코, 77900
- 모병
- University Hospital Olomouc
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연락하다:
- Vít Navrátil, MUDr, Ph.D.
- 전화번호: +420588445308
- 이메일: vit.navratil@fnol.cz
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약 그룹
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placebo with the same appearance as the probiotic supplement
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활성 비교기: 생균제 보충제
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: From enrollment to the end of supplementation at 6 weeks
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From enrollment to the end of supplementation at 6 weeks
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2차 결과 측정
결과 측정 |
기간 |
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Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires
기간: From enrollment to the end of supplementation at 6 weeks
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From enrollment to the end of supplementation at 6 weeks
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Evaluation of safety and tolerability of the preparation - prevalence of patient-reported adverse events as recorded in questionnaires
기간: From enrollment to the end of supplementation at 6 weeks
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From enrollment to the end of supplementation at 6 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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