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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Vít Navrátil, MUDr, Ph.D.
- 電話番号：+420588445308
- メール：vit.navratil@fnol.cz
研究場所
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-
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Olomouc、チェコ、77900
- 募集
- University Hospital Olomouc
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コンタクト：
- Vít Navrátil, MUDr, Ph.D.
- 電話番号：+420588445308
- メール：vit.navratil@fnol.cz
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ群
|
placebo with the same appearance as the probiotic supplement
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アクティブコンパレータ：プロバイオティクスサプリメント
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：From enrollment to the end of supplementation at 6 weeks
|
From enrollment to the end of supplementation at 6 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires
時間枠：From enrollment to the end of supplementation at 6 weeks
|
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
時間枠：From enrollment to the end of supplementation at 6 weeks
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From enrollment to the end of supplementation at 6 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。