Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT05119868
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2021-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 276}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of allergic disorders at 24 months of age in the offspring', 'timeFrame': '24 months from birth', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring'}], 'secondaryOutcomes': [{'measure': 'Maternal weight gain', 'timeFrame': 'From enrollment until delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain'}, {'measure': 'Pregnancy complications occurrence', 'timeFrame': 'From enrollment until delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence'}, {'measure': 'Perinatal complications occurrence', 'timeFrame': 'Delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence'}, {'measure': 'Neonatal birth weight', 'timeFrame': 'Delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices'}, {'measure': 'Body growth in the offspring', 'timeFrame': 'During the 24 months of life', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring'}, {'measure': 'Occurrence of any other chronic disorders in the first 2 years of age in the offspring', 'timeFrame': 'During the 24 months of life', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of any other chronic disorders in the first 2 years of age in the offspring'}, {'measure': "Mother's gut microbiome metagenomic features", 'timeFrame': 'From enrollment until delivery', 'description': "The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features"}, {'measure': "Mother's gut microbiome metabolomic features", 'timeFrame': 'From enrollment until delivery', 'description': "The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features"}, {'measure': "Son's gut microbiome metagenomic features", 'timeFrame': 'During the 24 months of life', 'description': "The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features"}, {'measure': "Son's gut microbiome metabolomic features", 'timeFrame': 'During the 24 months of life', 'description': "The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features"}, {'measure': 'Breastfeeding duration', 'timeFrame': 'During the 24 months of life', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration'}, {'measure': 'Breast milk composition', 'timeFrame': 'During the 24 months of life', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition'}, {'measure': 'Epigenetic modulation of genes involved in the regulation of immune system in the offspring', 'timeFrame': 'Delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the regulation of immune system in the offspring'}, {'measure': 'Epigenetic modulation of genes involved in the metabolic pathways in the offspring', 'timeFrame': 'Delivery', 'description': 'The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergies', 'Obesity', 'Gestational Complications', 'Gestational Weight Gain', 'Perinatal Condition', 'Birth Weight', 'Chronic Diseases in Children', 'Breast Feeding']}, 'referencesModule': {'references': [{'pmid': '36313083', 'type': 'DERIVED', 'citation': 'Coppola S, Paparo L, Chiariotti L, Ercolini D, Nocerino R, de Giovanni di Santa Severina AF, Carucci L, De Filippis F, Agangi A, Napolitano M, Passariello A, Messina F, Berni Canani R. Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study). Front Nutr. 2022 Oct 13;9:951223. doi: 10.3389/fnut.2022.951223. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby\n\nExclusion Criteria:\n\n* concomitant presence of infections;\n* concomitant presence of malignancies;\n* concomitant presence of major gastrointestinal malformations;\n* concomitant presence of immunodeficiencies;\n* concomitant presence of autoimmune diseases;\n* concomitant presence of chronic inflammatory bowel diseases;\n* concomitant presence of functional gastrointestinal disorders;\n* concomitant presence of celiac disease;\n* history of abdominal surgery with gastrointestinal resection;\n* concomitant presence of neuropsychiatric disorders;\n* concomitant presence of central nervous system disorders;\n* vegan diet;\n* twin pregnancy;\n* concomitant presence of genetic disorders;\n* concomitant presence of metabolic disorders.'}, 'identificationModule': {'nctId': 'NCT05119868', 'acronym': 'PREMEDI', 'briefTitle': 'Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)', 'orgStudyIdInfo': {'id': '283/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians', 'interventionNames': ['Other: Nutritional intervention based on Mediterranean Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'Group 2 will receive standard obstetrical and gynecological follow-up alone'}], 'interventions': [{'name': 'Nutritional intervention based on Mediterranean Diet', 'type': 'OTHER', 'description': 'A personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Berni Canani, MD, PhD', 'role': 'CONTACT', 'email': 'berni@unina.it', 'phone': '0817462680'}], 'facility': 'Department of Traslational Medical Science - University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80131', 'city': 'Naples', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Berni Canani', 'role': 'CONTACT', 'email': 'berni@unina.it', 'phone': '0817462680'}], 'facility': 'Department of Traslational Medical Science', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Roberto Berni Canani', 'role': 'CONTACT', 'email': 'berni@unina.it', 'phone': '0817462680'}], 'overallOfficials': [{'name': 'Roberto Berni Canani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Traslational Medical Science at University of Naples Federico II'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Roberto Berni Canani, MD, PhD', 'investigatorAffiliation': 'Federico II University'}}}}