Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective Randomized Trial
Primary Purpose
Clostridium Butyricum Miyairi, Gallstones, Gastrointestinal Quality of Life Index
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Miyarisan-BM (Clostridium Butyricum Miyairi)
Urso group
Biotase group
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Butyricum Miyairi
Eligibility Criteria
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
Sites / Locations
- Min sheng general hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Probiotics group
Urso group
Biotase group
Arm Description
Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months
ursodoxycholic acid, 200mg po tid x 6 months
Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
Outcomes
Primary Outcome Measures
Gallstones formation
Secondary Outcome Measures
serum total cholesterol and LDL level
Full Information
NCT ID
NCT03247101
First Posted
August 8, 2017
Last Updated
August 8, 2017
Sponsor
Min-Sheng General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03247101
Brief Title
Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective Randomized Trial
Official Title
Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Min-Sheng General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Butyricum Miyairi, Gallstones, Gastrointestinal Quality of Life Index
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics group
Arm Type
Experimental
Arm Description
Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months
Arm Title
Urso group
Arm Type
Active Comparator
Arm Description
ursodoxycholic acid, 200mg po tid x 6 months
Arm Title
Biotase group
Arm Type
Active Comparator
Arm Description
Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
Intervention Type
Drug
Intervention Name(s)
Miyarisan-BM (Clostridium Butyricum Miyairi)
Intervention Description
40mg po tid x 6months
Intervention Type
Drug
Intervention Name(s)
Urso group
Intervention Description
ursodoxycholic acid, 200mg po tid x 6 months
Intervention Type
Drug
Intervention Name(s)
Biotase group
Intervention Description
Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
Primary Outcome Measure Information:
Title
Gallstones formation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
serum total cholesterol and LDL level
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Min sheng general hospital
City
Taoyuan city
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
1858735
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.
Results Reference
result
PubMed Identifier
8385075
Citation
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.
Results Reference
result
PubMed Identifier
1612328
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. doi: 10.1016/0016-5085(92)91115-k.
Results Reference
result
PubMed Identifier
10757929
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. doi: 10.1381/096089293765559278.
Results Reference
result
PubMed Identifier
8213711
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.
Results Reference
result
PubMed Identifier
35232647
Citation
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.
Results Reference
derived
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Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective Randomized Trial
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