Probiotic treatment for children with new onset Type 1 Diabetes
Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
This study is testing if a special probiotic can help children who have just been diagnosed with Type 1 Diabetes by improving their gut health and preserving their insulin production over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT05767450 on ClinicalTrials.gov |
What this trial studies
This pilot proof of concept clinical trial aims to restore gut barrier integrity in children with new onset Type 1 Diabetes by administering a beneficial probiotic strain, Vivomixx®, for 90 days. The study is designed as a randomized, single-blind, placebo-controlled trial with two arms, where participants will receive either the probiotic or a placebo. The primary endpoint is to measure the preservation of insulin-producing beta-cell mass through changes in C-peptide levels after 12 months. Additional analyses will include blood and fecal samples to assess biomarkers and microbiome changes.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 18 years who have been diagnosed with insulin-dependent Type 1 Diabetes within the last three months and are positive for at least one islet autoantibody.
Not a fit: Patients with celiac disease, inflammatory bowel disease, or other significant immune dysfunctions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help preserve insulin production in children newly diagnosed with Type 1 Diabetes.
How similar studies have performed: While this approach is innovative, similar studies targeting gut microbiome interventions in autoimmune conditions have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan, Milan
- Autoimmune Pathogenesis Unit — Milan, Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Marika Falcone — IRCCS San Raffaele
- Study coordinator: Marika Falcone, MD
- Email: falcone.marika@hsr.it
- Phone: 00390226434890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.