Journal of Pediatric Perspectives

Journal of Pediatric Perspectives

Effect of Probiotic Supplementation on Glycemic and Inflammatory Markers in Children with Type 1 Diabetes: A Double-Blind Clinical Study

Articles in Press

Document Type : original article

Authors
Zahra Oroji 1
Peyman Eshraghi 1
Hamid Ahanchian 1
Mojtaba Lotfi 1
Sepideh Bagheri 1
Tahereh Sadeghi 2
1 Department of Pediatrics, School of Medicine, Akbar Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Department of Pediatrics, Nursing and Midwifery Care Research Center, Akbar Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
10.22038/jpp.2026.95081.5670
Abstract
Background: Type 1 diabetes mellitus (T1DM) 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 T1DM.
Objectives: This study aimed to evaluate the effects of oral probiotic supplementation on glycemic control, inflammatory markers, and metabolic parameters in children with T1DM.
Methods: In this randomized, double-blind, placebo-controlled clinical trial, 60 children with type 1 diabetes mellitus were randomly assigned to receive either BioDiab® probiotic capsules (3 × 10⁹ CFU/capsule) containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bacillus coagulans or identical placebo capsules daily for three months. HbA1c, high-sensitivity C-reactive protein (hs-CRP), insulin dose, lipid profile, anthropometric, thyroid, and renal parameters were assessed at baseline and at 3, 6, and 9 months. Data were analyzed using repeated measures ANOVA and other appropriate statistical tests.
Results: HbA1c levels significantly decreased in the probiotic group compared with an increase in the placebo group (P=0.017). Median hs-CRP levels demonstrated a downward trend in the probiotic group, with significant within-group changes over time (P=0.026), though intergroup differences were not statistically significant (P>0.05). 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 6-month follow-up (P=0.027).
Conclusion: Oral probiotic supplementation in children with T1DM 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.
Keywords
Glycemic control
Inflammation
Probiotics
Type 1 diabetes mellitus
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Journal of Pediatric Perspectives

Articles in Press, Accepted Manuscript
Available Online from 03 August 2026