The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13Months Follow-Up.

Abstract

The effect of probiotic supplements among subjects undergoing bariatric surgery indicates conflicting results. Moreover, whether these effects remain after ceasing the treatment remained to be elucidated. This study was conducted to assess the effect of probiotic supplements on blood markers of endotoxin (lipopolysaccharides-binding protein: LBP), inflammation and lipid peroxidation (malondialdehyde: MDA) in patients with morbid obesity undergoing the one-anastomosis gastric bypass (OAGB). This study is a placebo-controlled, double-blind, and randomized clinical trial and 9months of additional follow-up. Forty-six morbid obese patients undergoing OAGB were randomized to 4months of probiotic or placebo supplements. Anthropometric indices and blood concentration of LBP, inflammatory markers, MDA, vitamin D3, and B12 were measured at 0, 4, and 13months of study. Probiotic supplements could improve serum LBP (P = 0.039), TNF-α (P = 0.005), vitamin B12 (P = 0.03), vitamin D3 (P = 0.001), and weight loss (P = 0.01) at month 4 in comparison to placebo; however, only serum MDA concentrations decreased significantly in the probiotic group compared with those in the placebo group (P = 0.013) at the end of follow-up period. It was observed that 4months probiotic supplementation compared with placebo prohibited an elevation in the LBP levels and improved serum TNF-α and 25-OH vitamin D3 concentrations and weight loss in patients undergoing the OAGB surgery. However, these effects did not persist 9months after the cessation of the treatment. Further investigations are required to find how long supplementation and which dosage of it can benefit body status for the long-term. This study has been registered at Clinicaltrial.gov with registration number NCT02708589 .