Probiotic Yogurt in Patients With Chronic Cholecystitis (GR5-CC)
Efficacy and Safety of Pediococcus Acidilactici GR-5 in Patients With Chronic Cholecystitis: A Randomized Double-Blind Placebo-Controlled Trial
Background and Purpose: Chronic cholecystitis is a common disease causing gallbladder inflammation, which is closely related to imbalances in gut bacteria and bile acids. This study aims to investigate whether consuming a special functional yogurt containing the probiotic Pediococcus acidilactici GR-5 can help alleviate the symptoms of chronic cholecystitis.
Study Procedures: Researchers will recruit 50 patients with chronic cholecystitis and randomly divide them into two groups. For 30 days, one group will consume the functional GR-5 probiotic yogurt, while the other group will consume regular commercial yogurt (placebo). During the study period, researchers will use abdominal imaging to check the gallbladder, evaluate clinical symptoms, and collect blood and stool samples at baseline and after the 30-day intervention. The goal is to see if this probiotic yogurt can improve gallbladder health by regulating gut bacteria and bile acid metabolism, potentially providing a new dietary and nutritional option for patients with cholecystitis.
調査の概要
状態
条件
詳細な説明
Scientific Background: The pathogenesis of chronic cholecystitis is closely associated with the accumulation of conjugated bile acids and the dysbiosis of gut microbiota. Previous studies indicate that Pediococcus acidilactici GR-5, a probiotic isolated from traditional fermented foods, possesses high bile salt hydrolase (BSH) activity. It can efficiently deconjugate bile acids, thereby potentially reducing cytotoxicity and inflammatory stimulation in the gallbladder mucosa. This study aims to evaluate the clinical efficacy and underlying mechanisms of GR-5 functional yogurt in managing chronic cholecystitis via the "gut-biliary axis."
Study Design and Intervention: This is a prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients diagnosed with chronic cholecystitis will be randomly assigned in a 1:1 ratio to receive either the functional GR-5 probiotic yogurt (intervention group) or an ordinary yogurt without GR-5 (control group) for 30 days. To ensure strict double-blinding, an independent third party will handle the generation of the random sequence and the de-identified packaging. Both yogurt products will be completely identical in appearance, color, smell, and taste.
Data Collection and Multi-omics Analysis: The observation period spans 30 days. At baseline (Day 0) and at the end of the intervention (Day 30), researchers will conduct clinical evaluations, morphological imaging of the biliary tract, and collect fasting peripheral blood and fecal samples. To explore the deep mechanisms, multi-omics technologies, including 16S rRNA high-throughput sequencing and targeted/untargeted metabolomics of bile acids, will be utilized. By dynamically monitoring the changes in the gut microbiome and bile acid metabolic profiles before and after the intervention, this study expects to provide scientific evidence for using targeted functional microecological therapies to reshape intestinal homeostasis and alleviate biliary inflammation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：wei xiang, phD
- 電話番号：+86 13811760257
- メール：xiangw2023@lzu.edu.cn
研究連絡先のバックアップ
- 名前：wei xiang
- 電話番号：13811760257
- メール：xiangw2023@lzu.edu.cn
研究場所
-
-
Gansu
-
Lanzhou、Gansu、中国、730000
- School of Life Sciences, Lanzhou University
-
コンタクト：
- wei xiang, phD
- 電話番号：+86 13811760257
- メール：xiangw2023@lzu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male or female, aged 18 to 70 years.
- Definitive diagnosis of chronic cholecystitis (with or without gallstones), referencing the Chinese Medical Association guidelines or relevant clinical diagnostic criteria.
- Presence of clinical symptoms including recurrent right upper quadrant discomfort or dull pain, or accompanying dyspeptic symptoms (such as abdominal bloating, belching, or nausea), with symptoms persisting or recurring for more than 3 months prior to enrollment.
- Imaging support: Abdominal ultrasound within 3 months prior to enrollment indicating gallbladder wall thickening (typically > 3 mm) or wall roughness.
- Voluntary participation and signed written informed consent form.
Exclusion Criteria:
- Acute exacerbation of cholecystitis, purulent or gangrenous cholecystitis, or accompanying biliary obstruction or severe cholangitis requiring emergency surgical intervention.
- History of cholecystectomy or other major gastrointestinal surgeries (e.g., gastric bypass, bowel resection).
- Comorbidities of other severe primary diseases or malignancies, including: severe cardiovascular, renal, or neurological diseases; severe liver diseases (e.g., cirrhosis, severe viral hepatitis); and malignancies (e.g., gallbladder cancer, gastrointestinal tumors).
- Pregnant or lactating women, or those planning to conceive during the study period.
- Use of the following medications or preparations within 4 weeks prior to enrollment: continuous use of antibiotics, other probiotic or prebiotic preparations; currently taking choleretic or litholytic drugs that may significantly affect bile acid metabolism (e.g., ursodeoxycholic acid).
- Known allergy to dairy products, yogurt, or any intervention ingredients, or having severe lactose intolerance.
- Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this clinical study.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental Group: GR-5 Yogurt
Participants assigned to this group will receive the functional yogurt containing Pediococcus acidilactici GR-5 (zero sucrose) daily for 30 days.
|
A functional yogurt product provided by Jiangruikang Company, containing the probiotic strain Pediococcus acidilactici GR-5, with zero sucrose.
Participants will consume it daily for 30 days.
|
|
プラセボコンパレーター：Placebo Comparator Group
Participants assigned to this group will receive regular commercial yogurt (zero sucrose, without GR-5 probiotic) daily for 30 days.
It is identical in appearance, color, smell, and taste to the functional yogurt.
|
An ordinary commercial yogurt product provided by Jiangruikang Company, with zero sucrose but without the GR-5 probiotic.
It is identical in appearance, color, smell, and taste to the functional yogurt.
Participants will consume it daily for 30 days.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Gallbladder Wall Thickness and Smoothness
時間枠：Baseline and Day 30
|
Assessed via abdominal ultrasound.
|
Baseline and Day 30
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Gut Microbiota Diversity and Abundance
時間枠：Baseline and Day 30
|
Analyzed using 16S rRNA gene sequencing of fecal samples.
|
Baseline and Day 30
|
|
Change from Baseline in Serum Metabolite Levels
時間枠：Baseline and Day 30
|
Measured using metabolomics analysis of blood samples.
|
Baseline and Day 30
|
|
Change from Baseline in Fecal Metabolite Levels
時間枠：Baseline and Day 30
|
Measured using metabolomics analysis of stool samples.
|
Baseline and Day 30
|
|
Change from Baseline in Liver Function Indicators
時間枠：Baseline and Day 30
|
Measured via standard serum biochemical analysis (including ALT, AST, ALP, and Bilirubin)
|
Baseline and Day 30
|
|
Change from Baseline in Complete Blood Count (CBC)
時間枠：Baseline and Day 30
|
Measured via standard hematology analysis.
|
Baseline and Day 30
|
|
Incidence of Treatment-Emergent Adverse Events
時間枠：Up to Day 30
|
Assessed through patient reporting, clinical observation, and physical examination.
|
Up to Day 30
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：xiangkai Li, phD、School of Life Sciences, Lanzhou University
- 主任研究者：wei xiang、School of Life Sciences, Lanzhou University
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
キーワード
その他の研究ID番号
- LZU-CC-GR5-2026
- 32370110 (その他の助成金/資金番号：National Natural Science Foundation of China)
- 24ZDWA005 (その他の助成金/資金番号：Gansu Province Science and Technology Major Project)
- 2026004 (その他の識別子：Pingliang Hospital of Integrated Traditional Chinese and Western Medicine)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Functional GR-5 Probiotic Yogurtの臨床試験
-
Baylor College of MedicineLawson Health Research Institute; Chr Hansenわからない
-
Lawson Health Research InstituteUniversity of Western Ontario, Canada; St. Joseph's Health Care London完了
-
National Institute for Medical Research, TanzaniaErasmus Medical Center; Lawson Health Research Institute; University of Western Ontario, Canada; Danone Institute International と他の協力者わからない
-
Ohio State University Comprehensive Cancer Center完了
-
University of WashingtonNational Cancer Institute (NCI)完了I期乳がん | 男性乳がん | II期乳がん | IIIA期乳がん | 吐き気と嘔吐アメリカ