NCT05767450Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Nov 2022
- Start date
- 16 Dec 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Type 1 diabetes
- NCT number
- NCT05767450
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 16 Dec 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing use of systemic medications other than insulin.
- Recent administration of antibiotics (1 months prior to treatment)
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 7 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Autoimmune Pathogenesis Unit Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.