An interventional study of Functional GR-5 Probiotic Yogurt and Placebo Yogurt in Chronic Cholecystitis, sponsored by LanZhou University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by LanZhou University · Not applicable, Interventional, and Treatment
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.
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.
192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.
This study's planned enrollment of 50 is below the median of 82 across 129 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →LanZhou University is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Change from Baseline in Gallbladder Wall Thickness and Smoothness
Assessed via abdominal ultrasound.
Time frame: Baseline and Day 30
Change from Baseline in Gut Microbiota Diversity and Abundance
Analyzed using 16S rRNA gene sequencing of fecal samples.
Time frame: Baseline and Day 30
Change from Baseline in Serum Metabolite Levels
Measured using metabolomics analysis of blood samples.
Time frame: Baseline and Day 30
Change from Baseline in Fecal Metabolite Levels
Measured using metabolomics analysis of stool samples.
Time frame: Baseline and Day 30
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
Change from Baseline in Complete Blood Count (CBC)
Measured via standard hematology analysis.
Time frame: Baseline and Day 30
Incidence of Treatment-Emergent Adverse Events
Assessed through patient reporting, clinical observation, and physical examination.
Time frame: Up to Day 30
Plan to share: No — To protect the privacy and confidentiality of the study participants, individual participant data (IPD) will not be shared.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Sep 2026, 2 months later.
Of 60 non-industry interventional studies with no phase under Cholecystitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 2 months is below that.
Counting every sponsor, half of 64 studies reached it within 18 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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