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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03247101
Enrollment
180
Registered
2017-08-11
Start date
2016-02-29
Completion date
2017-12-31
Last updated
2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Butyricum Miyairi, Gallstones, Gastrointestinal Quality of Life Index

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.

Interventions

DRUGUrso group

ursodoxycholic acid, 200mg po tid x 6 months

DRUGBiotase group

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

Sponsors

Min-Sheng General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Gallstones formation6 months

Secondary

MeasureTime frame
serum total cholesterol and LDL level6 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026