Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-28 @ 8:18 AM
Study NCT ID:
NCT05767450
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention on New Onset-T1D Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be randomized in blind (by a computer) in 1:1 allocations. Participants enrolled in both arms and their parents wil be blinded to treatment as sachets provided will be identical as will be the visual aspect and taste of the Vivomixx probiotic.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional, randomized (1:1), 2-arm, single-center, placebo controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preservation of the residual insulin-producing beta cell mass', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Glycemic control by Time-in-Range (TIR) monitoring', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Gut barrier integrity', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Gut microbiome profile', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Measurement by flow cytometry of differences in the percentages of regulatory and inflammatory CD4 T cells', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Changes in circulating regulatory and inflammatory CD4 T cell subsets (Treg, Th1, Th2, Th17) will be evaluated by flow cytometry of the expression of:\n\n* CD4, FOXP3 (Treg)\n* CD4, CRTH2 (Th2)\n* CD4, Tbet (Th1)\n* CD4, RORgt (Th17)\n\nResults will be expressed in term of percentage (%) of CD4 T cells expressing the molecules'}, {'measure': 'Measurement by flow cytometry of differences in the percentages of MAIT cells and TCR gamma Delta T cells', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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\n\nResults 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)'}, {'measure': 'Measurement by flow cytometry of differences in the percentages of innate lymphoid cells', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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\n\nResults will be expressed in term of percentage (%) of Lineage-negative cells expressing c-kit or CRTH2 molecules.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiome', 'Intestinal barrier integrity'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26779542', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16973917', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23990830', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is an interventional randomized, 2-arm, single-blind, single-center, placebo-controlled mechanistic clinical trial (1:1).\n\nOne 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of insulin-dependent type 1 diabetes\n* Positive for at least one islet autoantibody (ICA, GADA, IA-2, IAA, ZnT8)\n* No more than 3 months from first insulin injection\n* ≥ 7 to \\< 18 year old\n\nExclusion Criteria:\n\n* Diagnosed with celiac disease, IBD or other intestinal inflammatory pathologies\n* 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.\n* Ongoing use of systemic medications other than insulin.\n* Recent administration of antibiotics (1 months prior to treatment)\n* 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.'}, 'identificationModule': {'nctId': 'NCT05767450', 'briefTitle': 'Intervention on New Onset-T1D Children', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'RF-2019-123-70721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated', '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', 'interventionNames': ['Dietary Supplement: Probiotic Vivomixx®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Untreated', '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', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic Vivomixx®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['VSL#3', 'Visbiome®'], 'description': '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.', 'armGroupLabels': ['Treated']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Untreated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marika Falcone', 'role': 'CONTACT', 'email': 'falcone.marika@hsr.it', 'phone': '+390226434890'}], 'facility': 'Autoimmune Pathogenesis Unit', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Marika Falcone, MD', 'role': 'CONTACT', 'email': 'falcone.marika@hsr.it', 'phone': '00390226434890'}], 'overallOfficials': [{'name': 'Marika Falcone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Group Leader', 'investigatorFullName': 'Marika Falcone', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}