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

NCT03247101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-08-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Min-Sheng General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247101 on ClinicalTrials.gov