Research AppraisalSystematic Review

Gut microbiota-modulating interventions in paediatric type 1 diabetes: a systematic review and meta-analysis

European journal of pediatricsLlopis-Alonso, Inmaculada, Correa-Bares, Melania, Mercader-Ros, María Teresa et al.25 May 2026DOI

Clinical Snapshot

70CEBM
Evidence: ModerateSystematic Review

PICO Framework

P — PopulationChildren and adolescents aged ≤19 years with type 1 diabetes
I — InterventionOral probiotics, prebiotics, or synbiotics
C — ComparatorControl groups (placebo or standard care)
O — OutcomesPrimary: glycated haemoglobin, fasting blood glucose, total daily insulin dose, C-peptide. Secondary: immune-inflammatory markers, microbiota composition, intestinal permeability, safety

Bottom Line

This systematic review of 12 RCTs involving 808 children with type 1 diabetes suggests gut microbiota-modulating interventions may modestly improve glycaemic control, specifically HbA1c and fasting glucose levels. However, the evidence suffers from substantial heterogeneity in study design, intervention formulations, and outcome reporting. No effects were seen on insulin requirements or C-peptide levels. While biologically plausible and potentially beneficial, current evidence is insufficient to recommend specific probiotic, prebiotic, or synbiotic protocols for routine clinical use. The interventions appear safe but lack standardisation. Australian clinicians should await larger, well-designed paediatric trials before incorporating these interventions into standard T1DM management. Families interested in probiotics should be counselled about the preliminary nature of current evidence.

Evidence: Moderate

Key Findings

  • P Value: Significant for HbA1c and FBG, non-significant for insulin dose and C-peptide

  • Effect Size: Not specified in abstract

  • Primary Outcome: Significant reductions in glycated haemoglobin and fasting blood glucose

  • Nnt Or Sensitivity: Not calculable from available data

  • Confidence Interval: Not provided in abstract

Clinical Application

Limited by lack of specific formulation, dose, or duration recommendations Relevant to Australian paediatric endocrinology practice; probiotics available over-counter but not PBS-subsidised for T1DM; aligns with RACGP interest in complementary approaches to chronic disease management Children and adolescents with type 1 diabetes in routine clinical care

Abstract

To evaluate the efficacy and safety of gut microbiota-modulating interventions in children and adolescents with type 1 diabetes. A systematic review and meta-analysis was conducted according to PRISMA 2020. PubMed/MEDLINE, Scopus, Web of Science, and CENTRAL were searched from inception to 28 February 2026 for randomised controlled trials of oral probiotics, prebiotics, or synbiotics in participants aged ≤ 19 years with type 1 diabetes. Primary outcomes were glycated haemoglobin, fasting blood glucose, total daily insulin dose, and C-peptide. Immune-inflammatory, microbiota-related, intestinal permeability, and safety outcomes were narratively synthesised. Twelve randomised controlled trials involving 808 paediatric participants were included. Interventions varied in formulation, dose, and duration. Pooled analyses showed significant reductions in glycated haemoglobin and fasting blood glucose, whereas no significant effects were found for total daily insulin dose or C-peptide. Immune-inflammatory, microbiota-related, and intestinal permeability outcomes suggested possible benefits, but reporting was inconsistent and quantitative pooling was not feasible. Overall, the evidence was limited by substantial clinical and methodological heterogeneity. Conclusion: Gut microbiota-modulating interventions may improve glycaemic control in children and adolescents with type 1 diabetes, particularly glycated haemoglobin and fasting blood glucose. However, current evidence is insufficient to support any specific formulation, dose, or duration, and larger well-designed paediatric trials are still needed. What is Known: • Gut microbiota-modulating interventions are biologically plausible adjunctive strategies in paediatric type 1 diabetes. • Earlier paediatric reviews included few randomised trials and reported inconsistent glycaemic findings. What is New: • This updated review included 12 randomised controlled trials involving 808 children and adolescents. • It adds a structured synthesis of immune-inflammatory, microbiota/barrier, metabolite-related and safety outcomes beyond glycaemic endpoints.

References

  1. 1.Llopis-Alonso, I., Correa-Bares, M., Mercader-Ros, M. T., Lucas-Abellán, C., García-Muñoz, A. M., & Victoria-Montesinos, D. (2026). Gut microbiota-modulating interventions in paediatric type 1 diabetes: a systematic review and meta-analysis. European Journal of Pediatrics. https://doi.org/10.1080/19490976.2020.1758008
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