Synbiotic supplementation in type one diabetes mellitus: A Randomized Controlled Clinical Trial

Background: limited studies have been conducted on the effect of synbiotics supplementation on Type 1 Diabetes Mellitus (T1DM). The current study aimed to evaluate the impacts of synbiotic supplementation on glycemic parameters, lipid profile, and vitamin D levels in children with T1DM.Methods: In this double-blind, randomized controlled trial, 86 T1DM patients aged 4-18 were randomly divided into two equal groups. One group received insulin and a synbiotic supplement once daily for 12 weeks; another group received insulin and a placebo. FBS (fasting blood sugar), HbA1C (hemoglobin A1c), triglycerides, cholesterol, HDL (High-density lipoprotein), LDL (low-density lipoprotein), and vitamin D levels were measured at the beginning and end of the study in both groups.Results: The trend of FBS, HbA1C, triglycerides, cholesterol, HDL, LDL, and vitamin D changes was not significant over time in both groups. Based on the analysis of covariance, the means of FBS and HbA1C were lower in the intervention group (p=0.048 and 0.025, respectively). However, no significant changes in triglycerides, cholesterol, HDL, LDL, and vitamin D levels were observed between the two groups (p= 0.291, 0.291, 0.952, 0.140, and 0.557, respectively).Conclusion: It’s suggested that insulin treatment in combination with synbiotic supplementation could improve FBS and HbA1C in T1DM children but had no effects on lipid profile and vitamin D levels.