NCT03247101

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Min-Sheng General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clostridium Butyricum Miyairi
• Gallstones
• Gastrointestinal Quality of Life Index

Interventions

Type	Name	Description
DRUG	Miyarisan-BM (Clostridium Butyricum Miyairi)	40mg po tid x 6months
DRUG	Urso group	ursodoxycholic acid, 200mg po tid x 6 months
DRUG	Biotase group	Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-08-11
• Last updated: 2017-08-11

Locations

1 site across 1 country: Taiwan