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Probiotic Yogurt in Patients With Chronic Cholecystitis (GR5-CC)

12 juin 2026 mis à jour par: Wei Xiang, LanZhou University

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Gansu
      • Lanzhou, Gansu, Chine, 730000
        • School of Life Sciences, Lanzhou University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: Functional GR-5 Probiotic Yogurt
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.
Comparateur placebo: 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.
Complément alimentaire: Placebo 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Gallbladder Wall Thickness and Smoothness
Délai: Baseline and Day 30
Assessed via abdominal ultrasound.
Baseline and Day 30

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Gut Microbiota Diversity and Abundance
Délai: Baseline and Day 30
Analyzed using 16S rRNA gene sequencing of fecal samples.
Baseline and Day 30
Change from Baseline in Serum Metabolite Levels
Délai: Baseline and Day 30
Measured using metabolomics analysis of blood samples.
Baseline and Day 30
Change from Baseline in Fecal Metabolite Levels
Délai: Baseline and Day 30
Measured using metabolomics analysis of stool samples.
Baseline and Day 30
Change from Baseline in Liver Function Indicators
Délai: 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)
Délai: Baseline and Day 30
Measured via standard hematology analysis.
Baseline and Day 30
Incidence of Treatment-Emergent Adverse Events
Délai: Up to Day 30
Assessed through patient reporting, clinical observation, and physical examination.
Up to Day 30

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

LanZhou University

Collaborateurs

Pingliang Hospital of Integrated Traditional Chinese and Western Medicine

Les enquêteurs

  • Directeur d'études: xiangkai Li, phD, School of Life Sciences, Lanzhou University
  • Chercheur principal: wei xiang, School of Life Sciences, Lanzhou University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

12 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • LZU-CC-GR5-2026
  • 32370110 (Autre subvention/numéro de financement: National Natural Science Foundation of China)
  • 24ZDWA005 (Autre subvention/numéro de financement: Gansu Province Science and Technology Major Project)
  • 2026004 (Autre identifiant: Pingliang Hospital of Integrated Traditional Chinese and Western Medicine)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

To protect the privacy and confidentiality of the study participants, individual participant data (IPD) will not be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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