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NCT06287931 Clinical Trial

Probiotics for Gallstones in Post-bariatric Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:
Probiotics for Gallstones in Post-bariatric Surgery Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06287931
Other study ID # sdllycyy001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date June 1, 2025

Study information
Verified date February 2024
Source Shandong Linglong Yingcheng Hospital
Contact Xuan Qiu, MD
Phone 8618354280081
Email qiuxuan100@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Patients receiving bariatric surgery for morbid obesity - Patiets at ages between 20 to 60 y/o - Patients willing to follow up regulary after bariatric surgery Exclusion Criteria: - Patients having gallstones before bariatric surgery - Patients refusing taking probiotics or refusing regular follow up after bariatric surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ursodoxycholic acid group
Ursodoxycholic acid, 250mg po tid x 6 months
• Bifidobacterium group
Bifidobacteria, 210 mg po tid x 6 months

Locations
Country Name City State
China Shandong Linglong Yingcheng Hospital Yantai Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong Linglong Yingcheng Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of gallstones in bariatric surgery patients 1 year
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