Actively Recruiting
Intervention on New Onset-T1D Children
Led by IRCCS San Raffaele · Updated on 2024-12-02
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intervention on New Onset-T1D Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Aged 7 to under 18 years old
You will not qualify if you...
- Diagnosed with celiac disease, inflammatory bowel disease, or other intestinal inflammatory conditions
- Diagnosed with tuberculosis, hepatitis B or C, HIV, or active EBV or CMV infection
- Significant cardiac disease or immune dysfunction conditions including malignancy, lymphopenia, thrombocytopenia, or anemia
- Liver or kidney dysfunction
- Ongoing use of systemic medications other than insulin
- Recent use of antibiotics within 1 month prior to treatment
- Unlikely or unable to comply with the study protocol or having medical issues or abnormal lab results increasing risk or interfering with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Autoimmune Pathogenesis Unit
Milan, Milan, Italy, 20132
Actively Recruiting
Research Team
M
Marika Falcone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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