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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: wei xiang, phD
- Número de telefone: +86 13811760257
- E-mail: xiangw2023@lzu.edu.cn
Estude backup de contato
- Nome: wei xiang
- Número de telefone: 13811760257
- E-mail: xiangw2023@lzu.edu.cn
Locais de estudo
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Gansu
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Lanzhou, Gansu, China, 730000
- School of Life Sciences, Lanzhou University
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Contato:
- wei xiang, phD
- Número de telefone: +86 13811760257
- E-mail: xiangw2023@lzu.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
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Comparador de 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Gallbladder Wall Thickness and Smoothness
Prazo: Baseline and Day 30
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Assessed via abdominal ultrasound.
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Baseline and Day 30
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Gut Microbiota Diversity and Abundance
Prazo: Baseline and Day 30
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Analyzed using 16S rRNA gene sequencing of fecal samples.
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Baseline and Day 30
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Change from Baseline in Serum Metabolite Levels
Prazo: Baseline and Day 30
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Measured using metabolomics analysis of blood samples.
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Baseline and Day 30
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Change from Baseline in Fecal Metabolite Levels
Prazo: Baseline and Day 30
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Measured using metabolomics analysis of stool samples.
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Baseline and Day 30
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Change from Baseline in Liver Function Indicators
Prazo: Baseline and Day 30
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Measured via standard serum biochemical analysis (including ALT, AST, ALP, and Bilirubin)
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Baseline and Day 30
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Change from Baseline in Complete Blood Count (CBC)
Prazo: Baseline and Day 30
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Measured via standard hematology analysis.
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Baseline and Day 30
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Incidence of Treatment-Emergent Adverse Events
Prazo: Up to Day 30
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Assessed through patient reporting, clinical observation, and physical examination.
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Up to Day 30
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: xiangkai Li, phD, School of Life Sciences, Lanzhou University
- Investigador principal: wei xiang, School of Life Sciences, Lanzhou University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- LZU-CC-GR5-2026
- 32370110 (Número de outro subsídio/financiamento: National Natural Science Foundation of China)
- 24ZDWA005 (Número de outro subsídio/financiamento: Gansu Province Science and Technology Major Project)
- 2026004 (Outro identificador: Pingliang Hospital of Integrated Traditional Chinese and Western Medicine)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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