Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial
NCT ID: NCT03247101
Last Updated: 2017-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2016-02-29
2017-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Probiotics group
Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months
Miyarisan-BM (Clostridium Butyricum Miyairi)
40mg po tid x 6months
Urso group
ursodoxycholic acid, 200mg po tid x 6 months
Urso group
ursodoxycholic acid, 200mg po tid x 6 months
Biotase group
Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months
Biotase group
Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months
Interventions
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Miyarisan-BM (Clostridium Butyricum Miyairi)
40mg po tid x 6months
Urso group
ursodoxycholic acid, 200mg po tid x 6 months
Biotase group
Biotase 1# \[Biodiastase 30mg + lipase 65mg + newlase 10mg\]/tab po tid x 6 months
Eligibility Criteria
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Inclusion Criteria
2. Patiets at ages between 20 to 65 y/o
3. Patients willing to follow up regulary after bariatric surgery.
Exclusion Criteria
2. Patients refusing taking probiotics or refusing regular follow up after bariatric surgery
20 Years
65 Years
ALL
No
Sponsors
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Min-Sheng General Hospital
OTHER
Responsible Party
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Locations
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Min sheng general hospital
Taoyuan, , Taiwan
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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MSIRB2016006
Identifier Type: -
Identifier Source: org_study_id
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