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

NCT03247101 | Unknown DMC

• 1 other identifier: MSIRB2016006
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gallstones formation

  6 months

Secondary Outcomes (1)

• serum total cholesterol and LDL level

  6 months

Study Arms (3)

Probiotics group

EXPERIMENTAL

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

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Urso group

ACTIVE COMPARATOR

ursodoxycholic acid, 200mg po tid x 6 months

Drug: Urso group

Biotase group

ACTIVE COMPARATOR

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

Drug: Biotase group

Interventions

Miyarisan-BM (Clostridium Butyricum Miyairi) DRUG

40mg po tid x 6months

Probiotics group

Urso group DRUG

ursodoxycholic acid, 200mg po tid x 6 months

Urso group

Biotase group DRUG

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

Biotase group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving bariatric surgery for morbid obesity
• Patiets at ages between 20 to 65 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

• Min-Sheng General Hospital: lead

Study Sites (1)

Min sheng general hospital

Taoyuan, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 1858735 RESULT

• 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.

  PMID: 8385075 RESULT

• 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. doi: 10.1016/0016-5085(92)91115-k.

  PMID: 1612328 RESULT

• 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. doi: 10.1381/096089293765559278.

  PMID: 10757929 RESULT

• 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.

  PMID: 8213711 RESULT

• Han ML, Lee MH, Lee WJ, Chen SC, Almalki OM, Chen JC, Wu CC. Probiotics for gallstone prevention in patients with bariatric surgery: A prospective randomized trial. Asian J Surg. 2022 Dec;45(12):2664-2669. doi: 10.1016/j.asjsur.2022.01.120. Epub 2022 Feb 26.

  PMID: 35232647 DERIVED

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

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2016-08

Locations

TW (1)