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New treatment option for Type 1 Diabetes
Official title Intervention on New Onset-T1D Children
ClinicalTrials.gov ID: NCT05767450
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.