Intervention on New Onset-T1D Children

San Donato Group (GSD)

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic Vivomixx®

Study type: Interventional

Funder types: Other

Identifiers

NCT05767450

RF-2019-123-70721

Details and patient eligibility

About

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.

Full description

This is an interventional randomized, 2-arm, single-blind, single-center, placebo-controlled mechanistic clinical trial (1:1).

One sachet of probiotic for children < 10 years old or two sachets for subjects > 10 years old dissolved into water or noncarbonated drinks will be administered every day for 90 consecutive days.The primary end point of the study will be the preservation of the residual insulin-producing beta-cell mass measured as the change in C-peptide values at 12 months after the beginning of treatment. Moreover, the investigators will collect blood samples for serological analysis (autoantibodies detection, measurement of biomarkers of gut barrier integrity) and immunological profiling; fecal samples for microbiome and metabolomic analysis. Finally the investigators will assess whether the response to Vivomixx® probiotic remains stable over a long-term period, that is in the absence of active treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Treated

Experimental group

Description:

Probiotic name: Vivomixx® Form: powder Dosage: 4,4g/sachet with 450 billion of lactobacilli and bifidobacteria in a base of maltose Frequency: 1 sachet/day for children \<10 year old or 2 sachets/day for children \>10 year old Duration: 90 days

Treatment:

Dietary Supplement: Probiotic Vivomixx®

Untreated

Placebo Comparator group

Description:

Product name: Placebo Form: powder Dosage: 4,4g/sachet containing maltose Frequency: 1 sachet/day for children \<10 year old or 2 sachets/day for children \>10 year old Duration: 90 days

Treatment:

Dietary Supplement: Placebo