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 13 Months Follow-Up
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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 9 months of additional follow-up. Forty-six morbid obese patients undergoing OAGB were randomized to 4 months 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 13 months 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 4 months 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 9 months 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.
KeywordsProbiotics Obesity Endotoxin Bariatric surgery Gastric surgery
The authors thank all participants and the staffs of Rasoul Hospital, without whom this study was impossible. This study is supported financially by the Shahid Beheshti University of Medical Sciences with grant number: SBMU/6010.
Z M and A H conceptualized and designed the study and wrote the manuscript; Z M and Z K collected data; A P, A K, and P M provided the study administration works. A H interpreted the data, provided professional comments, and critically revised the manuscript for intellectual content and data accuracy.
All authors had access to the study data and reviewed and approved the final manuscript.
This study was supported by a grant from the Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
Informed consent was obtained from all individual participants included in the study. All patients signed the informed consent form.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Institutional Review Board Statement
The study was approved by the Ethics Committee of the National Nutrition and Food Technology Research Institute, Tehran, Iran.
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