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

Gallstones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03247101
• Other study ID #: MSIRB2016006
• Status: Active, not recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 8, 2017
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Min-Sheng General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Taiwan	Min sheng general hospital	Taoyuan city

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Shiffman ML, Sugerman HJ, Kellum JH, Brewer WH, Moore EW. Gallstones in patients with morbid obesity. Relationship to body weight, weight loss and gallbladder bile cholesterol solubility. Int J Obes Relat Metab Disord. 1993 Mar;17(3):153-8. — View Citation

Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5. — View Citation

Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. — View Citation

Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. — View Citation

Worobetz LJ, Inglis FG, Shaffer EA. The effect of ursodeoxycholic acid therapy on gallstone formation in the morbidly obese during rapid weight loss. Am J Gastroenterol. 1993 Oct;88(10):1705-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallstones formation		6 months
Secondary	serum total cholesterol and LDL level		6 months