Probiotics for Gallstones in Post-bariatric Surgery Patients

NCT06287931 | Recruiting

• 1 other identifier: sdllycyy001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bariatric Surgery Candidate; Gallstone; Probiotics

Outcome Measures

Primary Outcomes (1)

• The incidence of gallstones in bariatric surgery patients

  1 year

Study Arms (3)

Ursodoxycholic acid group

EXPERIMENTAL

Ursodoxycholic acid, 250mg po tid x 6 months

Drug: Ursodoxycholic acid group

Bifidobacterium group

EXPERIMENTAL

Bifidobacteria, 210 mg po tid x 6 months

Drug: Bifidobacterium group

Bifidobacterium and ursodeoxycholic acid group

EXPERIMENTAL

Ursodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months

Drug: Ursodoxycholic acid group; Drug: Bifidobacterium group

Interventions

Ursodoxycholic acid group DRUG

Ursodoxycholic acid, 250mg po tid x 6 months

Bifidobacterium and ursodeoxycholic acid group; Ursodoxycholic acid group

Bifidobacterium group DRUG

Bifidobacteria, 210 mg po tid x 6 months

Bifidobacterium and ursodeoxycholic acid group; Bifidobacterium group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients having gallstones before bariatric surgery
• Patients refusing taking probiotics or refusing regular follow up after bariatric surgery

Sponsors & Collaborators

• Shandong Linglong Yingcheng Hospital: lead

Study Sites (1)

Shandong Linglong Yingcheng Hospital

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuan Qiu, MD

CONTACT

8618354280081; qiuxuan100@163.com

Ni Wang, MD,PD

CONTACT

8618705353551; wangni1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)