An interventional study of Ursodoxycholic acid group and Bifidobacterium group in Bariatric Surgery Candidate, Gallstone and Gallstone Attack, sponsored by Shandong Linglong Yingcheng Hospital. Recruiting at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Shandong Linglong Yingcheng Hospital · Not applicable, Interventional, and Prevention
Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 400 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Shandong Linglong Yingcheng Hospital is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Ursodoxycholic acid, 250mg po tid x 6 months
Drug: Ursodoxycholic acid group
Bifidobacteria, 210 mg po tid x 6 months
Drug: Bifidobacterium group
Ursodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months
Drug: Ursodoxycholic acid group · Drug: Bifidobacterium group
Ursodoxycholic acid, 250mg po tid x 6 months
Bifidobacteria, 210 mg po tid x 6 months
The incidence of gallstones in bariatric surgery patients
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jun 2025, 17 months after the start.
Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 17 months is below that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.
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Studies of the drug tested here: Bifidobacterium spp.
Shandong Linglong Yingcheng Hospital