Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 3:05 PM
Study NCT ID:
NCT06943469
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TransEpidermal Water Loss (TEWL) at 3 months', 'timeFrame': 'At 3 months of age', 'description': 'TransEpidermal water loss will be measured using a validated non-invasive technique.'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of Atopic Dermatitis', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Cumulative incidence of AD is based on physician diagnosis using the United Kingdom Working Party (UKWP) diagnosis criteria.'}, {'measure': 'TransEpidermal Water Loss', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Epidermal water loss will be measured using a validated non-invasive technique.'}, {'measure': 'Skin surface (stratum corneum) hydration', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Skin hydration will be measured with a corneometer device.'}, {'measure': 'Extent and severity of Atopic Dermatitis', 'timeFrame': 'From 3 months to 12 months of age', 'description': 'SCORAD (SCORing for Atopic Dermatitis), scores range from 0 to 103, with higher scores indicating higher atopic dermatitis severity'}, {'measure': 'Cumulative use of topical steroids and calcineurin inhibitors', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Use of medication to treat AD and other symptoms will be collected via parent self-reported questionnaire.'}, {'measure': 'Skin cytokines', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Concentration of skin cytokines such as IL4 and IL5 using immunoassays'}, {'measure': 'Skin natural moisturizing factors', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Concentration of skin natural moisturizing factors such as Pyrrolidone carboxylic acid, using HPLC'}, {'measure': 'Skin stratum corneum lipids', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Concentration of skin stratum corneum lipids such as ceramides, cholesterol and triacylglycerol using mass spectrometry'}, {'measure': 'Skin microbiome', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Overall skin microbiome composition and diversity using next-generation sequencing'}, {'measure': 'Skin metabolites', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Levels of skin metabolites using targeted or untargeted approaches.'}, {'measure': 'Immune proteomics', 'timeFrame': 'From enrollment to 6 months of age', 'description': 'Levels of plasma proteins using mass cytometry or immunoassaysand immunoassays.'}, {'measure': 'Immune blood cell immunophenotyping', 'timeFrame': 'From enrollment to 6 months of age', 'description': 'Levels of immune cell populations using mass cytometry or immunoassays'}, {'measure': 'Specific IgE antibodies', 'timeFrame': 'At 12 months of age', 'description': 'Specific IgE antibodies will be measured using Phadiatop infant®.'}, {'measure': 'Fecal microbiome', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology'}, {'measure': 'Fecal metabolites', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Levels of fecal metabolites using targeted or untargeted approaches.'}, {'measure': 'Fecal biomarkers of inflammation and immunity', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Levels of fecal markers of immune health and inflammation such as total secretory IgA (sIgA), calprotectin, and α-1-antitrypsin assessed by ELISA.'}, {'measure': 'Physician-diagnosed allergic manifestations', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Number of participants with Physician-diagnosed allergic manifestations.'}, {'measure': 'Gastrointestinal tolerance', 'timeFrame': 'At enrollment and 4 months of age', 'description': 'Infant Gastrointestinal Symptom Questionnaire (IGSQ), scores range from 13 to 65, with higher scores indicating higher gastrointestinal discomfort.'}, {'measure': 'Weight', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Weight (g and z-scores)'}, {'measure': 'Height', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Length (cm and z-scores)'}, {'measure': 'Head circumference', 'timeFrame': 'From enrollment to 12 months of age', 'description': 'Head circumference (cm and z-scores)'}, {'measure': 'Safety assessment', 'timeFrame': 'From enrollment to 13 months of age', 'description': 'Incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis (AD)']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable\n2. Infant gestational age ≥ 37 completed weeks\n3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg\n4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment\n5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.\n6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire\n7. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.\n\n or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.\n8. Parents/LAR must be able to provide evidence of parental authority and identity.\n9. Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.\n2. Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.\n3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.\n4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.\n5. Infant's parents or LARs have not reached legal age of majority (18 years)."}, 'identificationModule': {'nctId': 'NCT06943469', 'acronym': 'SPHINX', 'briefTitle': 'Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)', 'orgStudyIdInfo': {'id': '2215INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test formula', 'description': 'Partially hydrolyzed formula with synbiotics', 'interventionNames': ['Other: Test formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control formula', 'description': 'Intact protein formula without synbiotics', 'interventionNames': ['Other: Control formula']}, {'type': 'NO_INTERVENTION', 'label': 'Reference arm', 'description': 'Breastfed arm (not applicable for France)'}], 'interventions': [{'name': 'Test formula', 'type': 'OTHER', 'description': 'Partially hydrolyzed formula with synbiotics', 'armGroupLabels': ['Test formula']}, {'name': 'Control formula', 'type': 'OTHER', 'description': 'Intact protein formula without synbiotics', 'armGroupLabels': ['Control formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luc Cornette, Dr', 'role': 'CONTACT'}], 'facility': 'AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yvan Vandenplas, Pr', 'role': 'CONTACT'}], 'facility': 'Universitair Ziekenhuis Brussel - Kinderziekenhuis', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sabine Jespers, Dr', 'role': 'CONTACT'}], 'facility': 'Clinique Ste Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'André Léké, Dr', 'role': 'CONTACT'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geraldine Favrais, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Blandine Rébeillé Borgella', 'role': 'CONTACT'}], 'facility': 'CHU de Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Charles Picaud, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mireille Castanet, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Kristen Joseph-Delaffon, Dr', 'role': 'CONTACT'}], 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kirsten Beyer, Pr', 'role': 'CONTACT'}], 'facility': 'Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Monika Gappa, Pr', 'role': 'CONTACT'}], 'facility': 'Evangelisches Krankenhaus Düsseldorf - Frauenklinik', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Katharina Bluemchen, PD Dr', 'role': 'CONTACT'}], 'facility': 'Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Spandau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frank Jochum, PD Dr', 'role': 'CONTACT'}], 'facility': 'Evangelisches Waldkrankenhaus Spandau', 'geoPoint': {'lat': 52.5511, 'lon': 13.19921}}, {'city': 'Wesel', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Cordula Koerner-Rettberg, Dr', 'role': 'CONTACT'}], 'facility': 'Marien Hospital Wesel GmbH', 'geoPoint': {'lat': 51.6669, 'lon': 6.62037}}, {'city': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Moreno Álvarez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Teresa Herrera', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Almería', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Galera Martínez, Dr', 'role': 'CONTACT'}], 'facility': 'HU Torrecárdenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hector Boix, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Quiron Salud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Luz Garcia, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Severo Ochoa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Ramón Baca Cots, Dr', 'role': 'CONTACT'}], 'facility': 'Grupo Pediátrico Uncibay', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Salamanca de la Cueva, Dr', 'role': 'CONTACT'}], 'facility': 'Instituto Hispalense de Pediatria (IHP)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esther Parada Ricart, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari de Tarragona Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joaquín Escribano Subias, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Sant Joan de Reus', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gerardo Rodríguez Martínez, Dr', 'role': 'CONTACT'}], 'facility': 'HCU Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Amelie Goyer, PhD', 'role': 'CONTACT', 'email': 'Amelie.Goyer1@rd.nestle.com', 'phone': '+41217858939'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}