Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Autoimmune Pathogenesis Unit
RECRUITING
Milan
Contact Information
Primary
Marika Falcone, MD
falcone.marika@hsr.it
00390226434890
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Treated
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
Placebo_comparator: Untreated
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
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele