S Sherf-Dagan1,2,3, S Zelber-Sagi1,4, G Zilberman-Schapira5, M Webb1, A Buch1,3, A Keidar2,6, A Raziel2, N Sakran2,7, D Goitein2,3,8, N Goldenberg2, J A Mahdi5,9, M Pevsner-Fischer5, N Zmora5,10,11, M Dori-Bachash5, E Segal12, E Elinav5, O Shibolet1,3. 1. Department of Gastroenterology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel. 2. Assuta Medical Center, Tel Aviv, Israel. 3. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 4. School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel. 5. Immunology Department, Weizmann Institute of Science, Rehovot, Israel. 6. Department of General Surgery, Assuta Ashdod Public Hospital, Affiliated to the Ben-Gurion University, Beer-Sheba, Israel. 7. Department of Surgery A, Emek Medical Center, Afula, Israel. 8. Department of Surgery C, Sheba Medical Center, Tel Hashomer, Israel. 9. Department of Microbiology Immunology and Genetics, Ben-Gurion University, Beer-Sheba, Israel. 10. Research Center for Digestive Tract and Liver Diseases, Tel-Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 11. Internal Medicine Department, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel. 12. Department of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
Abstract
BACKGROUND:Probiotics are commonly used after bariatric surgery; however, uncertainty remains regarding their efficacy. Our aim was to compare the effect of probiotics vs placebo on hepatic, inflammatory and clinical outcomes following laparoscopic sleeve gastrectomy (LSG). METHODS: This randomized, double-blind, placebo-controlled, trial of 6-month treatment with probiotics (Bio-25; Supherb) vs placebo and 6 months of additional follow-up was conducted among 100 morbidly obese nonalcoholic fatty liver disease (NAFLD) patients who underwent LSG surgery. The primary outcome was a reduction in liver fat content, measured by abdominal ultrasound, and secondary outcomes were improvement of fibrosis, measured by shear-wave elastography, metabolic and inflammatory parameters, anthropometrics and quality of life (QOL). Fecal samples were collected and analyzed for microbial composition. RESULTS:One hundred patients (60% women, mean age of 41.9±9.8 years and body mass index of 42.3±4.7 kg m-2) were randomized, 80% attended the 6-month visit and 77% completed the 12-month follow-up. Fat content and NAFLD remission rate were similarly reduced in the probiotics and placebo groups at 6 months postsurgery (-0.9±0.5 vs -0.7±0.4 score; P=0.059 and 52.5 vs 40%; P=0.262, respectively) and at 12 months postsurgery. Fibrosis, liver-enzymes, C-reactive protein (CRP), leptin and cytokeratin-18 levels were significantly reduced and QOL significantly improved within groups (P⩽0.014 for all), but not between groups (P⩾0.173 for all) at 6 and 12 months postsurgery. Within-sample microbiota diversity (alpha-diversity) increased at 6-month postsurgery compared with baseline in both study arms (P⩽0.008) and decreased again at 12 months postsurgery compared with 6 months postsurgery (P⩽0.004) but did not reach baseline values. CONCLUSIONS:Probiotics administration does not improve hepatic, inflammatory and clinical outcomes 6- and 12 months post-LSG.
RCT Entities:
BACKGROUND: Probiotics are commonly used after bariatric surgery; however, uncertainty remains regarding their efficacy. Our aim was to compare the effect of probiotics vs placebo on hepatic, inflammatory and clinical outcomes following laparoscopic sleeve gastrectomy (LSG). METHODS: This randomized, double-blind, placebo-controlled, trial of 6-month treatment with probiotics (Bio-25; Supherb) vs placebo and 6 months of additional follow-up was conducted among 100 morbidly obese nonalcoholic fatty liver disease (NAFLD) patients who underwent LSG surgery. The primary outcome was a reduction in liver fat content, measured by abdominal ultrasound, and secondary outcomes were improvement of fibrosis, measured by shear-wave elastography, metabolic and inflammatory parameters, anthropometrics and quality of life (QOL). Fecal samples were collected and analyzed for microbial composition. RESULTS: One hundred patients (60% women, mean age of 41.9±9.8 years and body mass index of 42.3±4.7 kg m-2) were randomized, 80% attended the 6-month visit and 77% completed the 12-month follow-up. Fat content and NAFLD remission rate were similarly reduced in the probiotics and placebo groups at 6 months postsurgery (-0.9±0.5 vs -0.7±0.4 score; P=0.059 and 52.5 vs 40%; P=0.262, respectively) and at 12 months postsurgery. Fibrosis, liver-enzymes, C-reactive protein (CRP), leptin and cytokeratin-18 levels were significantly reduced and QOL significantly improved within groups (P⩽0.014 for all), but not between groups (P⩾0.173 for all) at 6 and 12 months postsurgery. Within-sample microbiota diversity (alpha-diversity) increased at 6-month postsurgery compared with baseline in both study arms (P⩽0.008) and decreased again at 12 months postsurgery compared with 6 months postsurgery (P⩽0.004) but did not reach baseline values. CONCLUSIONS: Probiotics administration does not improve hepatic, inflammatory and clinical outcomes 6- and 12 months post-LSG.
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