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

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. Participants received the probiotic or placebo in addition to standard diabetes care and a dietitian-guided meal plan.

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. Each capsule contained 112.5 billion viable lyophilized bacteria. For the probiotic arm, 47 participants were randomized and 45 were analyzed/completed.

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 in total insulin and bolus insulin, respectively, compared with 5 (11.4%) in placebo (p = 0.001 and p < 0.001). C-peptide did not differ (p = 0.971), and glucose variability findings were mixed: overall variability improved, but fasting glucose variability favored placebo. Mild bloating and flatulence were reported in 2 (4.4%) participants.

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. Some outcomes were mixed, including no C-peptide effect and differing results for fasting versus overall glucose variability, and the mechanism of benefit was not clarified.