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

Sponsor

Min-Sheng General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03247101

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clostridium Butyricum Miyairi Gallstones Gastrointestinal Quality of Life Index	Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) Drug: Urso group Drug: Biotase group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Probiotics group

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

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

40mg po tid x 6months

Active Comparator: Urso group

ursodoxycholic acid, 200mg po tid x 6 months

Drug: Urso group

ursodoxycholic acid, 200mg po tid x 6 months

Active Comparator: Biotase group

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

Drug: Biotase group

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

Outcome Measures

Primary Outcome Measures

Gallstones formation [6 months]

Secondary Outcome Measures

serum total cholesterol and LDL level [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Patients having gallstones before bariatric surgery
Patients refusing taking probiotics or refusing regular follow up after bariatric surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Min sheng general hospital	Taoyuan city		Taiwan

Sponsors and Collaborators

Min-Sheng General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min-Sheng General Hospital

ClinicalTrials.gov Identifier:

NCT03247101

Other Study ID Numbers:

MSIRB2016006

First Posted:

Aug 11, 2017

Last Update Posted:

Aug 11, 2017

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Gallstones

Cholelithiasis

Cholecystolithiasis

Study Results

No Results Posted as of Aug 11, 2017