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NCT07654985
Probiotic Yogurt in Patients With Chronic Cholecystitis
Conditions: Chronic Cholecystitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: LanZhou University
Location: School of Life Sciences, Lanzhou University Lanzhou Gansu
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07654985). StuddyBuddy aggregates publicly available trial information.