Intervention on New Onset-T1D Children
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Gut microbiome, Intestinal barrier integrity
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.
Sites / Locations
- Autoimmune Pathogenesis UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treated
Untreated
Probiotic name: Vivomixx® Form: powder Dosage: 4,4g/sachet with 450 billion of lactobacilli and bifidobacteria in a base of maltose Frequency: 1 sachet/day for children <10 year old or 2 sachets/day for children >10 year old Duration: 90 days
Product name: Placebo Form: powder Dosage: 4,4g/sachet containing maltose Frequency: 1 sachet/day for children <10 year old or 2 sachets/day for children >10 year old Duration: 90 days