Intervention on New Onset-T1D Children

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

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.

Conditions2

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