Tests a probiotic in children newly diagnosed with type 1 diabetes
Tests a probiotic against placebo in children with new-onset type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Intervention on New Onset-T1D Children
Key facts
- Where
- Milan, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 17 years old?
Source: NCT05767450, who can take part
Where in Italy
- Autoimmune Pathogenesis UnitMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT05767450
- Record updated
- 2 December 2024
- Original description
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.Read full original descriptionShow less
Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
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.
Inclusion: 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: Ongoing use of systemic medications other than insulin; Recent administration of antibiotics (1 months prior to treatment); 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; 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.