Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial
Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery.
This was a placebo-controlled, double-blind, randomized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study.
At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B12, folate, and homocysteine between groups at week 16 of the study.
Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies.
This study has been registered at Clinicaltrial.gov with registration number NCT02708589.
KeywordsProbiotics Gastric surgery Obesity OAGB-MGB One anastomosis gastric bypass- mini gastric bypass surgery Morbidity Clinical trial
We appreciate all participants and the staffs of Rasoul Hospital, without whom this study was impossible.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest. The study was financially supported by Endocrine Research Institute of SBMU with grant number 1394215/787.
Informed consent was obtained from all individual participants included in the study.
All procedures performed in this study were approved by the institutional research committee and in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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