Effect of Probiotic Supplementation on Glycemic and Inflammatory Markers in Children with Type ۱ Diabetes: A Double-Blind Clinical Study

Background: Type ۱ diabetes mellitus (T۱DM) is a prevalent metabolic disorder in childhood, marked by autoimmune destruction of pancreatic β-cells leading to insulin deficiency, hyperglycemia, and chronic inflammation. Achieving optimal glycemic control in children remains a challenge despite insulin therapy. Probiotics, with their immunomodulatory and metabolic benefits, have recently emerged as potential adjunctive agents for improving glycemic and inflammatory outcomes in T۱DM.Objectives: This study aimed to evaluate the effects of oral probiotic supplementation on glycemic control, inflammatory markers, and metabolic parameters in children with T۱DM.Methods: In this randomized, double-blind, placebo-controlled clinical trial, ۶۰ children with type ۱ diabetes mellitus were randomly assigned to receive either BioDiab® probiotic capsules (۳ × ۱۰⁹ CFU/capsule) containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bacillus coagulans or identical placebo capsules daily for three months. HbA۱c, high-sensitivity C-reactive protein (hs-CRP), insulin dose, lipid profile, anthropometric, thyroid, and renal parameters were assessed at baseline and at ۳, ۶, and ۹ months. Data were analyzed using repeated measures ANOVA and other appropriate statistical tests.Results: HbA۱c levels significantly decreased in the probiotic group compared with an increase in the placebo group (P=۰.۰۱۷). Median hs-CRP levels demonstrated a downward trend in the probiotic group, with significant within-group changes over time (P=۰.۰۲۶), though intergroup differences were not statistically significant (P>۰.۰۵). No significant effects were observed on lipid profile, thyroid indices, or daily insulin dose. However, blood urea nitrogen (BUN) levels were significantly lower in the probiotic group at ۶-month follow-up (P=۰.۰۲۷).Conclusion: Oral probiotic supplementation in children with T۱DM improved glycemic control and modulated inflammatory markers without adverse effects. While other metabolic parameters remained unchanged, probiotics may serve as a safe and beneficial adjunct to conventional diabetes management.

کلیدواژه ها:

Glycemic control ، Inflammation ، Probiotics ، Type ۱ Diabetes Mellitus