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AzTrials

Type 1 DiabetesNCT05767450

Intervention on New Onset-T1D Children

A study testing Probiotic Vivomixx® in people with Type 1 Diabetes, run by IRCCS San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Probiotic Vivomixx®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
16 Dec 2022to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marika Falcone, MD contact

00390226434890

falcone.marika@hsr.it

Italy1 site, 1 recruiting

  • Autoimmune Pathogenesis Unit

    Milan, Milan, 20132

    Marika Falcone, +390226434890, falcone.marika@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes

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.

Read the detailed 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.

Conditions
Type 1 Diabetes
Being tested
Probiotic Vivomixx®, Placebo
Keywords
Gut microbiome, Intestinal barrier integrity
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic Vivomixx®Dietary supplement

    Also called VSL#3, Visbiome®

    The correct number of Vivomixx® sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks.

  • PlaceboDietary supplement

    The correct number of Placebo sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks.

Study groups in NCT05767450
Study groupRoleWhat they receive
TreatedExperimentalProbiotic 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
Receives: Dietary Supplement: Probiotic Vivomixx®
UntreatedPlacebo comparatorProduct 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
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preservation of the residual insulin-producing beta cell mass

    The primary outcome of the study will be the preservation of the residual insulin-producing beta-cell mass in newly diagnosed T1D patients that received the probiotic Vivomixx® in comparison to those receiving placebo. This parameter will be reported as the change in C-peptide values (ng/mL) before starting treatment (baseline) and 12 months after treatment initiation.

    Measured: through study completion, an average of 1 year

  2. Glycemic control by Time-in-Range (TIR) monitoring

    Glycemic control will be monitored in newly diagnosed T1D patients that received the probiotic Vivomixx® in comparison to those receiving placebo. This parameter will be reported as the change in TIR values (%) - that is the percentage of time in which blood glucose (blood sugar) remains in the safe target range of 70-180mg/dL - recorded before starting treatment (baseline) and 12 months after treatment initiation.

    Measured: through study completion, an average of 1 year

Secondary outcomes (5)

  1. Gut barrier integrity

    The levels of zonulin and LBP will be measured in the serum before starting Vivomixx® or placebo administration (baseline), 3 months and 6 months after treatment initiation, as biomarkers used to determine the integrity of the intestinal epithelium in humans.

    Measured: through study completion, an average of 1 year

  2. Gut microbiome profile

    The gut microbiota composition will be analyzed on fecal samples collected before starting Vivomixx or placebo administration (baseline), 3 months and 6 months after treatment, 16S ribosomal RNA (rRNA) sequencing.

    Measured: through study completion, an average of 1 year

  3. Measurement by flow cytometry of differences in the percentages of regulatory and inflammatory CD4 T cells

    Changes in circulating regulatory and inflammatory CD4 T cell subsets (Treg, Th1, Th2, Th17) will be evaluated by flow cytometry of the expression of:

    • CD4, FOXP3 (Treg)
    • CD4, CRTH2 (Th2)
    • CD4, Tbet (Th1)
    • CD4, RORgt (Th17)

    Results will be expressed in term of percentage (%) of CD4 T cells expressing the molecules

    Measured: through study completion, an average of 1 year

  4. Measurement by flow cytometry of differences in the percentages of MAIT cells and TCR gamma Delta T cells

    Changes in circulating MAIT and TCR gammaDelta T cell subsets will be evaluated by flow cytometry of the expression of CD3, TCRgD, CD161, TCRva7.2

    Results will be expressed in term of percentage (%) of cells expressing CD3, TCRgD molecules (that are TCRgammaDelta T cells) and CD3, CD161, TCRva7.2 molecules (that are MAIT cells)

    Measured: through study completion, an average of 1 year

  5. Measurement by flow cytometry of differences in the percentages of innate lymphoid cells

    Changes in circulating MAIT and TCR gammaDelta T cell subsets will be evaluated by flow cytometry of the expression of Lineage markers, c-kit, CRTH2

    Results will be expressed in term of percentage (%) of Lineage-negative cells expressing c-kit or CRTH2 molecules.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start16 Dec 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Interventional, randomized (1:1), 2-arm, single-center, placebo controlled
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767450
Sponsor's protocol ID
RF-2019-123-70721
Status last verified
Nov 2024
First submitted
21 Nov 2022
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dolpady J, Sorini C, Di Pietro C, Cosorich I, Ferrarese R, Saita D, Clementi M, Canducci F, Falcone M. Oral Probiotic VSL#3 Prevents Autoimmune Diabetes by Modulating Microbiota and Promoting Indoleamine 2,3-Dioxygenase-Enriched Tolerogenic Intestinal Environment. J Diabetes Res. 2016;2016:7569431. doi: 10.1155/2016/7569431. Epub 2015 Dec 8.

    PubMed 26779542

  • Caballero-Franco C, Keller K, De Simone C, Chadee K. The VSL#3 probiotic formula induces mucin gene expression and secretion in colonic epithelial cells. Am J Physiol Gastrointest Liver Physiol. 2007 Jan;292(1):G315-22. doi: 10.1152/ajpgi.00265.2006. Epub 2006 Sep 14.

    PubMed 16973917

  • Korpela R, Niittynen L. Probiotics and irritable bowel syndrome. Microb Ecol Health Dis. 2012 Jun 18;23. doi: 10.3402/mehd.v23i0.18573. eCollection 2012.

    PubMed 23990830

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic Vivomixx® in people with Type 1 Diabetes, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marika Falcone, MD (00390226434890, falcone.marika@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preservation of the residual insulin-producing beta cell mass (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767450, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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