Effect of prebiotic intervention on glycemic control and gut microbiome profile in Indian children with type 1 diabetes mellitus (T1DM): a pilot randomised control trial.

BACKGROUND

Type 1 diabetes mellitus (T1DM) is increasingly associated with gut microbial dysbiosis. Emerging evidence suggests that short-chain fatty acids(SCFA) producing bacteria play a role in glucose regulation and immune modulation. However, interventional data in children remain limited.

OBJECTIVE

To evaluate the effect of an oligofructose-enriched inulin intervention on glycemic control and gut microbiome composition in Indian children with T1DM.

METHODS

In double-blind, randomised, placebo-controlled pilot trial, 68-children (8-18years) with established T1DM were allocated to receive either 8 g/day of oligofructose-enriched inulin or an isocaloric maltodextrin placebo for 12 weeks. Anthropometry, glycated-hemoglobin (HbA1c), and stool-microbiome-profiles (16SrRNA sequencing) were assessed at baseline and endline. Alpha and beta-diversity indices, differential abundance analyses(DESeq2), were compared between groups.

RESULTS

Sixty-one participants (32 prebiotic, 29 placebo) completed the study with a mean compliance of 80%. Baseline characteristics and HbA1c levels were comparable between groups. No significant difference in HbA1c was observed after intervention (prebiotic 9.8 ± 1.4% vs. placebo 10.6 ± 2.5%; p > 0.05). However, the prebiotic group demonstrated a significant enrichment of SCFA-producing taxa, including Intestinibacter, Lachnospiraceae_UCG004, Megasphaera, Prevotella_2, and Agathobacter(p < 0.05). Families such as Lachnospiraceae, Bifidobacteriaceae, Ruminococcaceae, Atopobiaceae and Akkermensiaceae were increased significantly, while alpha- and beta-diversity indices remained stable. No significant adverse events were reported apart from isolated mild hypoglycemic episodes.

CONCLUSIONS

Prebiotics intervention modulated beneficial gut bacteria(SCFA-producing) without any change in glycemic control, suggesting possible long-term metabolic and anti-inflammatory benefits in T1DM. Larger studies are needed. Adding natural prebiotic-rich foods to daily diets of children with T1DM could be a simple, affordable.