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Intervention on New Onset-T1D Children
Sponsor: IRCCS San Raffaele
Summary
A pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (Lactobacilli-enriched Vivomixx® probiotic) to new onset Type 1 Diabetes Children.
Official title: Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-12-16
Completion Date
2025-12-31
Last Updated
2024-12-02
Healthy Volunteers
No
Conditions
Interventions
Probiotic Vivomixx®
The correct number of Vivomixx® sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks.
Placebo
The correct number of Placebo sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks.
Locations (1)
Autoimmune Pathogenesis Unit
Milan, Milan, Italy