Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial

Min-Sheng General Hospital

Status: Unknown

Conditions: Gallstones; Clostridium Butyricum Miyairi; Gastrointestinal Quality of Life Index

Treatments: Drug: Biotase group; Drug: Miyarisan-BM (Clostridium Butyricum Miyairi); Drug: Urso group

Study type: Interventional

Funder types: Other

Identifiers

NCT03247101

MSIRB2016006

Details and patient eligibility

About

Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. Previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. Therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life.

Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. It consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.

Enrollment: 180 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients receiving bariatric surgery for morbid obesity
2. Patiets at ages between 20 to 65 y/o
3. Patients willing to follow up regulary after bariatric surgery.

Exclusion criteria

1. Patients having gallstones before bariatric surgery
2. Patients refusing taking probiotics or refusing regular follow up after bariatric surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

Probiotics group

Experimental group

Description:

Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months

Treatment:

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Urso group

Active Comparator group

Description:

ursodoxycholic acid, 200mg po tid x 6 months

Treatment:

Drug: Urso group

Biotase group

Active Comparator group

Description:

Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months

Treatment:

Drug: Biotase group