Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective
| Registry | NCT03247101 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 180 (Estimated) |
| Sponsor | Min-Sheng General Hospital (Other) |
| Conditions | Clostridium Butyricum Miyairi, Gallstones, Gastrointestinal Quality of Life Index |
| Interventions | Miyarisan-BM (Clostridium Butyricum Miyairi), Urso group, Biotase group (Drug) |
| Dates | start 2016-02-01, primary completion 2017-12-01 (estimated), completion 2017-12-01 (estimated), first posted 2017-08-11, last updated 2017-08-11 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Clostridium Butyricum Miyairi All trials for Gallstones All trials of Miyarisan-BM (Clostridium Butyricum Miyairi) All trials of Urso group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Probiotics group | Experimental | Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) | Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months |
| Urso group | Active comparator | Drug: Urso group | ursodoxycholic acid, 200mg po tid x 6 months |
| Biotase group | Active comparator | Drug: Biotase group | Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months |
Sex: All, ages: 20 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Min sheng general hospital | Taoyuan City | Taiwan |