Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT05371106
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2022-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycotoxins in Mothers Milk in Israel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'milk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-05-08', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mycotoxins in breastmilk', 'timeFrame': 'approx. 6 months after recruitment', 'description': 'To measure mycotoxins and mycotoxins metabolites levels in breast milk'}], 'secondaryOutcomes': [{'measure': 'Source of contamination', 'timeFrame': 'approx. one year after recruitment', 'description': 'To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mycotoxins'], 'conditions': ['Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '19875698', 'type': 'BACKGROUND', 'citation': 'Wild CP, Gong YY. Mycotoxins and human disease: a largely ignored global health issue. Carcinogenesis. 2010 Jan;31(1):71-82. doi: 10.1093/carcin/bgp264. Epub 2009 Oct 29.'}, {'pmid': '31694387', 'type': 'BACKGROUND', 'citation': 'Tesfamariam K, De Boevre M, Kolsteren P, Belachew T, Mesfin A, De Saeger S, Lachat C. Dietary mycotoxins exposure and child growth, immune system, morbidity, and mortality: a systematic literature review. Crit Rev Food Sci Nutr. 2020;60(19):3321-3341. doi: 10.1080/10408398.2019.1685455. Epub 2019 Nov 6.'}, {'pmid': '27300310', 'type': 'BACKGROUND', 'citation': 'Warth B, Braun D, Ezekiel CN, Turner PC, Degen GH, Marko D. Biomonitoring of Mycotoxins in Human Breast Milk: Current State and Future Perspectives. Chem Res Toxicol. 2016 Jul 18;29(7):1087-97. doi: 10.1021/acs.chemrestox.6b00125. Epub 2016 Jun 28.'}, {'pmid': '21864634', 'type': 'BACKGROUND', 'citation': 'El-Tras WF, El-Kady NN, Tayel AA. Infants exposure to aflatoxin M(1) as a novel foodborne zoonosis. Food Chem Toxicol. 2011 Nov;49(11):2816-9. doi: 10.1016/j.fct.2011.08.008. Epub 2011 Aug 16.'}]}, 'descriptionModule': {'briefSummary': "Some plant pathogen fungi may develop in grains, nuts and dry foodstuff during their storage. They secrete toxins which are very resistant and persistent.\n\nThe toxins enter the human body through the food. Women eating without their knowledge spoiled food absorb the toxin which is conveyed into their milk. In the same way, meat and dairy products can be contaminated with mycotoxins.\n\nToxins and their metabolites can have negative effects on pregnant women and on the fetus or infant health.\n\nThe main purpose of this trial is to assess the presence of toxins in mothers's milk.", 'detailedDescription': "Fungi from the genus Aspergillus, Penicillium, Fusarium and Alternaria can synthesize toxins. These may be carcinogenic, immunotoxic or endocrine disruptors.\n\nIn this trial, Zearalenone, Deoxynivalenol, T-2 toxin, Fumonisin B1, Fumonisin B2, Aflatoxin M1, Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2, Ochratoxin A, HT-2 toxin, De-epoxy-deoxynivalanol presence and quantity will be assessed in mother's milk.\n\nAnother purpose is to try to pinpoint at the source(s) of contamination."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 and above.\n* Pregnant women after week 37 intending to breastfeed.\n* Women breastfeeding.\n\nExclusion Criteria:\n\n* Women taking drugs which influence milk production.\n* Women taking drugs contraindicated during breastfeeding.\n* Women not staying in Israel during third trimester or in the months after birth for a long period of time.\n* Women not wanting/able to fill up the questionnaires.'}, 'identificationModule': {'nctId': 'NCT05371106', 'briefTitle': 'Mycotoxins in Mothers Milk in Israel', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': "Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life", 'orgStudyIdInfo': {'id': '224-20-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'breastfeeding mothers', 'description': 'pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months', 'interventionNames': ['Other: exposure to mycotoxins']}], 'interventions': [{'name': 'exposure to mycotoxins', 'type': 'OTHER', 'description': 'self-report eating questionnaire', 'armGroupLabels': ['breastfeeding mothers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Mati Berkovitch, Prof.', 'role': 'CONTACT', 'email': 'mberkovitch@shamir.gov.il', 'phone': '(972)89779152'}, {'name': 'Ariela M Hazan, BSc', 'role': 'CONTACT', 'email': 'arielah@shamir.gov.il', 'phone': '(972)89778465'}, {'name': 'Mati Berkovitch, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ariela Hazan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elkana Kohn, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'centralContacts': [{'name': 'Elkana Kohn, Ph.D.', 'role': 'CONTACT', 'email': 'elkanak@shamir.gov.il', 'phone': '972-8-9772181'}, {'name': 'Ariela M Hazan, BSc', 'role': 'CONTACT', 'email': 'arielah@shamir.gov.il', 'phone': '972-8-9778465'}], 'overallOfficials': [{'name': 'Elkana Kohn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shamir (Assaf Harofeh) Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'The study protocol will be shared with researchers', 'accessCriteria': 'interested colleagues'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}