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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics group | Experimental | Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months |
|
| Urso group | Active Comparator | ursodoxycholic acid, 200mg po tid x 6 months |
|
| Biotase group | Active Comparator | Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miyarisan-BM (Clostridium Butyricum Miyairi) | Drug | 40mg po tid x 6months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gallstones formation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum total cholesterol and LDL level | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Min sheng general hospital | Taoyuan City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1858735 | Result | 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. | |
| 8385075 | Result | 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. |
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| Urso group |
| Drug |
ursodoxycholic acid, 200mg po tid x 6 months |
|
| Biotase group | Drug | Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months |
|
| 1612328 | Result | 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. |
| 10757929 | Result | 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. |
| 8213711 | Result | 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. |
| 35232647 | Derived | 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. |
| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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