A high potency multi‐strain probiotic improves glycemic control in children with new‐onset type 1 diabetes mellitus: A randomized, double‐blind, and placebo‐controlled pilot study

Study answer

What this study found

Overall, adding the probiotic improved glycemic control and reduced insulin requirements over 3 months, with a higher remission rate than placebo. HbA1c decline was significantly greater in the probiotic group at 3 months (p = 0.021, PP; p = 0.012, ITT), and total insulin dose and bolus insulin dose also decreased more with probiotic treatment (p = 0.0037 and p = 0.02 for total insulin; p = 0.018 and p = 0.017 for bolus insulin). Remission occurred in 12 participants (26.6%) with probiotic versus 4 (8.8%) with placebo (p = 0.023), and 14 (31.1%) versus 17 (39.5%) achieved a >=50% reduction…

Study & population

This was a single-center, randomized, double-blind, placebo-controlled pilot trial in children aged 2 to 12 years with new-onset type 1 diabetes in India.

Intervention

The active intervention was a high-potency, multi-strain probiotic De Simone formulation (Visbiome® in India), given orally as 1 capsule daily for 3 months.

Key limitation

This was a small pilot study with short 3-month follow-up and single-center enrollment, so the findings are preliminary and may not generalize broadly.

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Original abstract