RECRUITINGINTERVENTIONAL
Intervention on New Onset-T1D Children
Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DIETARY_SUPPLEMENT
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.
DIETARY_SUPPLEMENT
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