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).
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.
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.
Probiotics administration does not improve hepatic, inflammatory and clinical outcomes 6- and 12 months post-LSG.
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This study was supported (in part) by grant no. 3-10470 from the Chief Scientist Office of the Ministry of Health, Israel. The funding source did not have a role in the design, conduct and analysis of the study or the decision to submit the manuscript for publication.
SS-D, SZ-S and OS designed and performed the study, analyzed the data and wrote the paper. GZ-S, EE, ES, JAM, MP-F, NZ and MD-B carried out the microbiota analysis. MW performed the US examinations and NG assisted in MRI decoding. AB, AK, AR, DG and NS assisted in data collection. All authors critically reviewed the manuscript, agreed to be fully accountable for ensuring the integrity and accuracy of the work and read and approved the final manuscript.
The authors declare no conflict of interest.
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Sherf-Dagan, S., Zelber-Sagi, S., Zilberman-Schapira, G. et al. Probiotics administration following sleeve gastrectomy surgery: a randomized double-blind trial. Int J Obes 42, 147–155 (2018). https://doi.org/10.1038/ijo.2017.210
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