Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-06 @ 5:03 AM
Study NCT ID:
NCT04160767
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation With a Probiotic (VIVOMIXX®) in a Cohoort of Celiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-09', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in vitamin B6, folic acid, vitamin B12 and 25'OH vitamin D levels in blood", 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in homocysteine levels in blood', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in ghrelin, chinolinic acid and serotonin levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in fecal metabolomics (including production of short chain fatty acids verified by gas-chromatography)', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in highly sensitive C reactive protein levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in erythrocite sedimentation rate', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in fibrinogen blood levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in IL-6 blood levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in Tumor Necrosis Factor alfa blood levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}], 'secondaryOutcomes': [{'measure': 'Changes in body mass index', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in systemic arterial systolic and diastolic blood pressure', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in height', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in weight', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in waist circumference', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Entity of reduction of triceps skinfold thickness', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in prevalence of aphtous stomatitis', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in chinolinic acid, serotonin, ghrelin levels in blood', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in complete cell blood count', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in total cholesterol levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in HDL cholesterol levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in LDL cholesterol levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in triglycerides levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in Apolipoprotein A1 levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in Apolipoprotein B levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in fasting glucose levels', 'timeFrame': 'T0 T1 (+4 months)'}, {'measure': 'Changes in fasting insulin levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in auto-antibody anti endomisium titer', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in auto-antibody anti-transglutaminase titer', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Changes in fecal calprotectin levels', 'timeFrame': 'Time point 0: day 0 Time point 1: after 4 months'}, {'measure': 'Prevalence of wildtype allele of MTHFR gene by gene sequencing', 'timeFrame': 'Time point 0: day 0 (at the enrollement)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Celiac disease', 'Gut microbiota'], 'conditions': ['Celiac Disease']}, 'descriptionModule': {'briefSummary': "Celiac disease is a disorder caused by a disregulation of the immune system which leads to immune response to gluten. Diet therapy is the gold standard of treatment, and the only effective one. Macronutrients and micronutrients deficiency (vitamin D, folic acid, vitamin B12, vitamin B6, iron and zinc), which is in any case far more common in patients who don't follow gluten free diet, can persist in a subset of patients who follow gluten-free diet. Supplementation of vitamins in these patients may have a beneficial role. A recent study in a murine model showed that supplementation with probiotic VIVOMIXX® leads to an increase in expression of vitamin D receptors in proximal and distal colon.\n\nThis is an interventional controlled randomized double blind study, which evaluates the effect of VIVOMIXX® on vitamin status.", 'detailedDescription': "90 patients with celiac disease who follow gluten free diet will be enrolled. INCLUSION CRITERIA\n\n* Celiac disease (diagnosis made according to ESPGHAN criteria) EXCLUSION CRITERIA\n* Supplementation with pre/probiotics in the previous 3 months;\n* Antibiotic therapy in the previous 3 months;\n* Comorbidity with other acute (in the previous 3 months) or chronic gastrointestinal disorders\n* Supplementation with group B vitamins for any reason\n\nPatients enrolled will be referred to Paediatric Gastroenterology Service in San Paolo Hospital at the time of enrollement (T0) and after intervention therapy (T1, + 4 months).\n\nPatients will be randomized in one of the two arms of intervention (VIVOMIXX once a day for 4 months versus placebo once a day for 4 months).\n\nVIVOMIXX® is a probiotic containing 8 differenct strains of bacteria: Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734). Every sachet contains 450 billions of bacteria, maltose and silicon dioxide. VIVOMIXX® will be freely given by the society MENDES S.A. - Lugano Switzerland.\n\nAt each time point clinic evaluation, nutritional assessment and blood testing will be made. Data collection will include:\n\n* Systemic arterial blood pressure;\n* Anthropometric measures (height, weight, body mass index, waist circumference, triceps skinfold)\n* Clinical evaluation including presence/absence of oral aphtous stomatitis\n* Measure of chinolinic acid, serotonin, ghrelin (analysis will be made at Istituto Malattie Infettive, Università La Sapienza, Roma).\n* Dosing of inflammatory markers (analysis will be made at Health Sciences Department, San Paolo Hospital).\n* Metabolomics on stool samples (analysis will be made at Bologna University, Dipartimento di Scienze e Tecnologie Agro-Alimentari, Cesena, with a financial fund by MENDES S.A. - Lugano Switzerland).\n* Routine blood testing including complete blood cell count, vitamin B6, acid folic, vitamin B12, vitamin D 25'OH, fasting glucose, fasting insulin, total cholesterol, LDL and HDL cholesterol, Apolipoprotein A1 and Apolipoprotein B, triglycerides, homocistein, auto-antibody anti endomisium and anti-transglutaminase,\n* Genetic testing for MTHFR gene\n* ESR, highly sensitive CRP, IL6, TNFalfa, fibrinogen\n* Fecal calprotectin."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Celiac disease (diagnosis made according to European Society for Paediatric Gastroenterology Hepatology and Nutrition)\n\nExclusion Criteria:\n\n* Supplementation with pre/probiotics in the previous 3 months;\n* Antibiotic therapy in the previous 3 months;\n* Comorbidity with other acute (in the previous 3 months) or chronic gastrointestinal disorders\n* Supplementation with group B vitamins for any reason'}, 'identificationModule': {'nctId': 'NCT04160767', 'acronym': 'VIVOMIXX', 'briefTitle': 'Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation With a Probiotic (VIVOMIXX®) in a Cohoort of Celiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': "Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation With a Probiotic (VIVOMIXX®) on Vitamin B6, B12, 25'OH D, Folic Acid and Omocystein Levels, Metabolic and Inflammatory Status, and Gut Microbiota Metabolomics in a Cohoort of Celiac Patients", 'orgStudyIdInfo': {'id': '2015/ST/135-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'interventionNames': ['Drug: Probiotic Vivomixx', 'Behavioral: Gluten free diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Behavioral: Gluten free diet', 'Other: Placebo']}], 'interventions': [{'name': 'Probiotic Vivomixx', 'type': 'DRUG', 'description': 'VIVOMIXX once a day for 4 months. VIVOMIXX® is a probiotic containing 8 differenct strains of bacteria: Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734). Every sachet contains 450 billions of bacteria, maltose and silicon dioxide. VIVOMIXX® will be freely given by the society MENDES S.A. - Lugano Switzerland.', 'armGroupLabels': ['Probiotic']}, {'name': 'Gluten free diet', 'type': 'BEHAVIORAL', 'description': 'Gluten free diet will be encouraged in both arms', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo with same taste than VIVOMIXX, containing maltose and silicon dioxide once a day for 4 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20142', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elvira Verduci, MD PhD Assistant Professor', 'role': 'CONTACT', 'email': 'elvira.verduci@unimi.it', 'phone': '+39 0281844508'}], 'facility': 'Ospedale San Paolo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Paediatrician, University of Milan Researcher', 'investigatorFullName': 'Elvira Verduci', 'investigatorAffiliation': 'University of Milan'}}}}