Postcholecystectomy Syndrome (PCS)
Conditions
Interventions
Group B: symptomatic + Bifidobacterium monotherapy group:Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live, 1.5 g each time, 3 times daily, taken after meals, fo
Group D: symptomatic + combination group (ursodeoxycholic acid + Bifidobacterium):ursodeoxycholic acid tablets+Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live
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Group A: symptomatic + ursodeoxycholic acid monotherapy group:ursodeoxycholic acid tablets, 10 mg/kg/day, divided into two doses, taken with meals, for 6 consecutive months.
Group C: symptomatic + standard follow-up control group:They did not accept study drug intervention, and allowed to use loperamide as needed to control diarrhea symptoms.
Group E: asymptomatic + standard follow-up observation group:No study drug intervention, maintain daily routines and habits, regular follow-up for 6 months, no rescue medication provided, single sampl
Sponsors
The First Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals who meet all of the following criteria are eligible for this study:; 1.Aged 18-75 years (inclusive), male or female. 2.Laparoscopic cholecystectomy for gallstones or benign polyps was performed, and the postoperative pathology confirmed that it was benign. 3.After cholecystectomy (>= 3 months after cholecystectomy), patients with dyspepsia symptoms (such as abdominal distension, diarrhea, fatty diarrhea, acid regurgitation, postprandial discomfort, etc.) were included in the symptomatic group. According to the gastrointestinal symptoms rating scale (gsrs-i), the total score of patients in the "dyspepsia syndrome" dimension was >= 2, or the score of at least one core symptom (abdominal distension, diarrhea) was >= 2; Asymptomatic patients with the above scores < 2 were included in the asymptomatic group. ). 4.Voluntarily participate in the study, be able to understand and sign the written informed consent, and be willing and able to comply with all research procedures and visit plans.
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria will not be eligible for this study:; 1.Previous history of colorectal cancer, advanced adenoma (including high-grade intraepithelial neoplasia, villous adenoma, adenoma with diameter >= 1cm) or inflammatory bowel disease (such as ulcerative colitis and Crohn's disease). 2.Systemic antibiotics, probiotics of any dosage form or prebiotic products were used within 1 month before enrollment. 3.It is known to be allergic to ursodeoxycholic acid or any component of Bifidobacterium preparations. 4.Suffering from uncontrolled severe systemic diseases (such as decompensated heart, lung, liver, and kidney diseases), active infections, or other major diseases judged by the investigator that may interfere with the evaluation of the study. 5.Chronic diarrhea, intestinal obstruction, cirrhosis (child Pugh B or C), active pancreatitis, or symptomatic biliary disease. 6.Participated in any other intervention clinical study within 3 months before enrollment. 7.Pregnant women, lactating women, or women/men of childbearing age were reluctant to take effective contraceptive measures during the study and within 1 month after the end of the study. 8.The investigator judged that there were any other circumstances that might put the subjects at inappropriate risk or affect their completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in postcholecystectomy syndrome core symptom composite score;Change in fecal microbiota alpha diversity;Change in fecal secondary bile acid proportion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in dyspepsia symptom score;Change in serum FGF19 level;Incidence of adverse events;Change in peripheral blood regulatory T cell proportion;Change in quality of life score;Change in serum inflammatory cytokine levels; | — |
Countries
China
Contacts
Public ContactYu Yaqun
The First Affiliated Hospital of Guilin Medical University
Outcome results
None listed