Health TrialsbyHealthPanel

Probiotic Yogurt in Patients With Chronic Cholecystitis

ConditionChronic Cholecystitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLanZhou University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental Group: GR-5 YogurtExperimental treatment 1 intervention
Group B: Placebo Comparator GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Gallbladder Wall Thickness and Smoothness

Assessed via abdominal ultrasound.

Time frame
Baseline and Day 30

Secondary outcomes

1

Change from Baseline in Gut Microbiota Diversity and Abundance

Analyzed using 16S rRNA gene sequencing of fecal samples.

Time frame
Baseline and Day 30
2

Change from Baseline in Serum Metabolite Levels

Measured using metabolomics analysis of blood samples.

Time frame
Baseline and Day 30
3

Change from Baseline in Fecal Metabolite Levels

Measured using metabolomics analysis of stool samples.

Time frame
Baseline and Day 30
4

Change from Baseline in Liver Function Indicators

Measured via standard serum biochemical analysis (including ALT, AST, ALP, and Bilirubin)

Time frame
Baseline and Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LanZhou University

Lead sponsor

Pingliang Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: