Effect of probiotics on honeymoon period duration and glycemic control of type one diabetes mellitus: A randomized controlled double blind clinical trial study protocol

Abstract

Abstract Background type 1 diabetes is one of the most chronic diseases of childhood. The therapeutic recommendation for this condition is quite complex and needs changes in lifestyle. Recently the role of gut microbiota has received attention as a possible mechanism in the pathogenesis and control of the disease. Methods One hundred thirty Children aged 6–18 years old with newly diagnosed diabetes type one participate in the trial they are randomly assigned to the intervention or control group. The patients will receive a six month course of probiotics or placebo besides their conventional treatment with insulin. And they will be followed for at least one year. Participants are followed at 3 month intervals for one year. At each visit anthropometrical data, glycemic control and total dose of insulin required to keep the optimal glycemic control is evaluated and registered. Discussion There is evidence that alterations in gut microbiota is seen in children with diabetes. In this study we aim to evaluate the effect of probiotic administration on the duration of honeymoon period in pediatrics with type one diabetes and their glycemic control and insulin requirements. Clinical trial registration: IRCT20200117046164N3