Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT07050693
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Nobody knows the randomization code'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double bind with placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'The dietary supplement and placebo will be administered for three months from the date of enrollment.', 'description': 'The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['food supplement', 'gastroenteric infection'], 'conditions': ['Gastroenteric Tract', 'Respiratory Tract', 'Infections', 'Gastroenteric Infections']}, 'referencesModule': {'references': [{'pmid': '34760912', 'type': 'BACKGROUND', 'citation': 'Siziba LP, Mank M, Stahl B, Kurz D, Gonsalves J, Blijenberg B, Rothenbacher D, Genuneit J. Associations of Human Milk Oligosaccharides With Otitis Media and Lower and Upper Respiratory Tract Infections up to 2 Years: The Ulm SPATZ Health Study. Front Nutr. 2021 Oct 25;8:761129. doi: 10.3389/fnut.2021.761129. eCollection 2021.'}, {'pmid': '25047751', 'type': 'BACKGROUND', 'citation': 'Etzold S, Bode L. Glycan-dependent viral infection in infants and the role of human milk oligosaccharides. Curr Opin Virol. 2014 Aug;7:101-7. doi: 10.1016/j.coviro.2014.06.005. Epub 2014 Jul 19.'}, {'pmid': '11387176', 'type': 'BACKGROUND', 'citation': 'Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.'}]}, 'descriptionModule': {'briefSummary': "Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.\n\nFunctional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.\n\nHealthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week\n\nExclusion Criteria:\n\n* Age less than 12 months and more than 48 months;\n* Concomitant presence of chronic diseases\n* Congenital heart disease;\n* Tuberculosis;\n* Functional gastrointestinal disorders;\n* Gastrointestinal or urinary surgery of the respiratory tract;\n* Autoimmune diseases;\n* Immunodeficiencies;\n* Chronic inflammatory bowel diseases;\n* Celiac disease;\n* Cystic fibrosis;\n* Metabolic diseases;\n* Lactose intolerance;\n* Tumors;\n* Chronic lung diseases and malformations of the gastrointestinal tract;\n* Food allergies;\n* Eosinophilic esophagitis;\n* Other hypereosinophilic diseases of the gastrointestinal tract;\n* Diarrhea at enrollment;\n* Severe malnutrition (z score for weight/height less than 3SD);\n* Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study;\n* Breastfeeding in progress'}, 'identificationModule': {'nctId': 'NCT07050693', 'acronym': 'IMMUNOSICK24', 'briefTitle': "Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.", 'organization': {'class': 'OTHER', 'fullName': 'University of Bari'}, 'officialTitle': "Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.", 'orgStudyIdInfo': {'id': 'IMMUNOSICK24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': "50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose", 'interventionNames': ['Dietary Supplement: Vitamin + Zinc + micronutrient mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '50 children will take a carbohydrate-based control product (maltodextrin)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Vitamin + Zinc + micronutrient mixture', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Experimental arm'], 'description': "a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.", 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo is identical to intervention product', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Bari', 'state': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ruggiero Francavilla, Prof', 'role': 'CONTACT', 'email': 'ruggiero.francavilla@uniba.it', 'phone': '00390805592063'}], 'facility': 'Pediatria Trambusti', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruggiero Francavilla', 'investigatorAffiliation': 'University of Bari'}}}}