Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of insulin-dependent type 1 diabetes * Positive for at least one islet autoantibody (ICA, GADA, IA-2, IAA, ZnT8) * No more than 3 months from first insulin injection * ≥ 7 to \< 18 year old Exclusion Criteria: * Diagnosed with celiac disease, IBD or other intestinal inflammatory pathologies * Diagnosed with tuberculosis, hepatitis B or C, HIV, or active EBV or CMV infection; significant cardiac disease; conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia); liver or renal dysfunction. * Ongoing use of systemic medications other than insulin. * Recent administration of antibiotics (1 months prior to treatment) * Deemed unlikely or unable to comply with the protocol or have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.