Probiotic treatment for children with new onset Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity

  This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.

  Recruiting Phase 2/3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07891156

• Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes

  This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.

  Recruiting at 11 sites Medtronic MiniMed, Inc. · Chula Vista, California and 17 other locations · NCT07864168

• CGM-guided carb awareness education for adults with Type 1 diabetes

  This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07807280

• Safety and effectiveness of GLP-1 receptor agonists and SGLT inhibitors added to insulin in adults with type 1 diabetes

  This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.

  Recruiting at 17 sites Indiana University · Newport Beach, California and 16 other locations · NCT07676565

• Think-Find-Solve activities for insulin self-management in children with type 1 diabetes

  A behavior-change activity book is tested with children aged 8–12 with type 1 diabetes and their parents to see if it improves daily insulin self-management.

  Recruiting Marmara University · Istanbul · NCT07670572

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.