Probiotics for Gallstones in Post-bariatric Surgery Patients

NCT ID: NCT06287931

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ursodoxycholic acid group

Ursodoxycholic acid, 250mg po tid x 6 months

Group Type EXPERIMENTAL

Ursodoxycholic acid group

Intervention Type DRUG

Ursodoxycholic acid, 250mg po tid x 6 months

Bifidobacterium group

Bifidobacteria, 210 mg po tid x 6 months

Group Type EXPERIMENTAL

Bifidobacterium group

Intervention Type DRUG

Bifidobacteria, 210 mg po tid x 6 months

Bifidobacterium and ursodeoxycholic acid group

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

Group Type EXPERIMENTAL

Ursodoxycholic acid group

Intervention Type DRUG

Ursodoxycholic acid, 250mg po tid x 6 months

Bifidobacterium group

Intervention Type DRUG

Bifidobacteria, 210 mg po tid x 6 months

Interventions

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Ursodoxycholic acid group

Ursodoxycholic acid, 250mg po tid x 6 months

Intervention Type DRUG

Bifidobacterium group

Bifidobacteria, 210 mg po tid x 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Linglong Yingcheng Hospital

NETWORK

Sponsor Role lead

Responsible Party

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Xuan Qiu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shandong Linglong Yingcheng Hospital

Yantai, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuan Qiu, MD

Role: CONTACT

8618354280081

Ni Wang, MD,PD

Role: CONTACT

8618705353551

Facility Contacts

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Xuan Qiu, MD

Role: primary

8618354280081

Ni Wang, MD

Role: backup

8618705353551

Other Identifiers

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sdllycyy001

Identifier Type: -

Identifier Source: org_study_id

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