Effect of Oral Synbiotic Consumption on Glycemic Control and Honeymoon Phase Duration in Children with Type 1 Diabetes: A Randomized Clinical Trial

Abstract

Background: The present study aimed to investigate the effects of synbiotics on glycemic control and the duration of the honeymoon phase in newly diagnosed children with type 1 diabetes mellitus (T1DM). Methods: This study is a randomized, triple-blind clinical trial conducted in Mashhad in 2023. The samples included children aged 2 to 18 years who were referred to the Endocrinology Clinic of Akbar Children’s Hospital. The patients were randomly divided into two groups: Synbiotic and placebo (60 participants in each group). The synbiotic group received capsules containing specific strains of Lactobacillus, Bifidobacterium, and Streptococcus thermophiles, while the placebo group received a placebo for six months. Blood sugar control indices, HbA1c, and lipid profiles were recorded at the beginning of the study and then at three-month intervals. The duration of the honeymoon period and the number of diabetic ketoacidosis attacks during treatment were also examined. Patients were followed up every three months for one year. Data were analyzed using SPSS version 22 software, and a 95% confidence level was considered. Results: After six months, the synbiotic group showed a significant decrease in total daily insulin dose compared to the placebo group (P = 0.000). No significant differences were observed in mean HbA1c levels between the two groups before the study and three months after synbiotic consumption (P > 0.05). However, after the six-month follow-up, the synbiotic group demonstrated a significant decrease in HbA1c levels (P = 0.039). At the end of the six months, the percentage of participants in the honeymoon phase differed significantly between the two groups, with 3.3% in the placebo group and 13.3% in the synbiotic group (P = 0.048). Conclusions: Synbiotic supplementation in children with T1DM can lead to improvements in glycemic control, including reduced insulin requirements, enhanced HbA1c levels, and a prolonged honeymoon phase. These outcomes highlight the potential of synbiotics as a supportive adjunct to standard diabetes management strategies for improving glycemic control in this population.