Probiotic Yogurt in Patients With Chronic Cholecystitis

NCT07654985 | Not Yet Recruiting

• 4 other identifiers: LZU-CC-GR5-20263237011024ZDWA0052026004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Cholecystitis

Keywords

Probiotics; Pediococcus acidilactici; Gut Microbiota; Bile Acids

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Gallbladder Wall Thickness and Smoothness

  Assessed via abdominal ultrasound.

  Baseline and Day 30

Secondary Outcomes (6)

• Change from Baseline in Gut Microbiota Diversity and Abundance

  Baseline and Day 30

• Change from Baseline in Serum Metabolite Levels

  Baseline and Day 30

• Change from Baseline in Fecal Metabolite Levels

  Baseline and Day 30

• Change from Baseline in Liver Function Indicators

  Baseline and Day 30

• Change from Baseline in Complete Blood Count (CBC)

  Baseline and Day 30

Study Arms (2)

Experimental Group: GR-5 Yogurt

EXPERIMENTAL

Participants assigned to this group will receive the functional yogurt containing Pediococcus acidilactici GR-5 (zero sucrose) daily for 30 days.

Dietary Supplement: Functional GR-5 Probiotic Yogurt

Placebo Comparator Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo Yogurt

Interventions

Functional GR-5 Probiotic Yogurt DIETARY_SUPPLEMENT

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.

Experimental Group: GR-5 Yogurt

Placebo Yogurt DIETARY_SUPPLEMENT

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.

Placebo Comparator Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LanZhou University: lead
• Pingliang Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (1)

School of Life Sciences, Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Study Officials

• xiangkai Li, phD

  School of Life Sciences, Lanzhou University

  STUDY DIRECTOR

• wei xiang

  School of Life Sciences, Lanzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei xiang, phD

CONTACT

+86 13811760257; xiangw2023@lzu.edu.cn

wei xiang

CONTACT

13811760257; xiangw2023@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)