Probiotics for Gallstones in Post-bariatric Surgery Patients

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06287931

Enrollment

400

Registered

2024-03-01

Start date

2024-01-01

Completion date

2025-06-01

Last updated

2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Gallstone, Gallstone Attack, Gastrointestinal Quality of Life Index, Probiotics

Keywords

Bariatric Surgery Candidate, Gallstone, Probiotics

Brief 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.

Interventions

DRUGUrsodoxycholic acid group

Ursodoxycholic acid, 250mg po tid x 6 months

DRUGBifidobacterium group

Bifidobacteria, 210 mg po tid x 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The incidence of gallstones in bariatric surgery patients	1 year

Countries

China

Contacts

Primary ContactXuan Qiu, MD

qiuxuan100@163.com8618354280081

Backup ContactNi Wang, MD,PD

wangni1989@163.com8618705353551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026