Trial reportEndocrine2026
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.
Trial report in Endocrine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
backgroundType 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.
objectiveTo evaluate the effect of an oligofructose-enriched inulin intervention on glycemic control and gut microbiome composition in Indian children with T1DM.
methodsIn 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.
resultsSixty-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.
conclusionsPrebiotics 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.
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