Gall stone disease was known to increase after bariatric surgery. Ursodeoxycholic acid (UDCA) might reduce the gallstone formation rate after bariatric surgery. However, other option for gallstone prevention was unclear. We reported the result of a randomized trial comparing the gallstone prevention efficacy of probiotics and digestive enzyme versus UDCA.
This prospective, randomized trial was held in an institute of Taiwan. Patients were eligible for inclusion if their body-mass index (BMI) was 32.5 kg/m2 or higher with the presence of comorbidity, or 27.5 kg/mw or higher with not-well controlled type 2 diabetes, and were aged 18-65 years. Participant were randomized assigned (1:1:1) to probiotic, digestive enzyme or UDCA. The primary endpoint was assessed in the incidence of gallstone disease at 6 months after surgery. This study is registered with ClinicalTrials.gov. number NCT03247101, and is now completed.
From January 2016 to December 2018, of 186 patients screened for eligibility, 152 were randomly assigned to probiotic (52) or digestive enzyme (52) or UDCA (52). In the per-protocol population, mean age was 35.9 years (SD 10.6), mean BMI was 40.3 kg/m2 (SD 6.9), 57(58.2%) were female. After 6 months, the incidence of gall bladder diseased was 15.2%, in the probiotics group, 17.6% in UDCA group and 29.1% in digestive enzyme groups, confirming non-inferiority of probiotic (p = 0.38). Female gender was identified as a risk factor for gall bladder disease after bariatric surgery (odds ratio = 4.61, 95% confidence interval = 1.05, 20.3, p = 0.04). The poor drug compliance rate was 19.5%, 22.7% and 26.2% in probiotics, UDCA and digestive enzyme group respectively. UDCA group had a higher drug adverse effect than probiotic group (15.9% vs. 2.4%, p = 0.03).
Probiotic is not inferior to UDCA regarding gall bladder disease prevention after bariatric surgery at 6 months.
Asian journal of surgery. 2022 Feb 26 [Epub ahead of print]
Ming-Lun Han, Ming-Hsien Lee, Wei-Jei Lee, Shu-Chun Chen, Owaid M Almalki, Jung-Chien Chen, Chun-Chi Wu
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Integrated Diagnostics & Therapeutics, National Taiwan University Hospital, Taipei, Taiwan., Metabolic & Bariatric Surgical Department, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan., Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan. Electronic address: ., Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan., Department of Surgery, College of Medicine, Taif University, Saudi Arabia.