Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 12:07 PM
Study NCT ID:
NCT06260956
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D021181', 'term': 'Egg Hypersensitivity'}, {'id': 'D021183', 'term': 'Peanut Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'C000625000', 'term': 'SAV4 protein, Arabidopsis'}], 'ancestors': [{'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory: Peanut sensitization', 'timeFrame': 'four months', 'description': 'The proportion of high-risk infants who have developed peanut sensitization'}, {'measure': 'Exploratory: Egg sensitization', 'timeFrame': 'four months', 'description': 'Proportion of infants who develop egg sensitization.'}, {'measure': 'Exploratory: Symptoms', 'timeFrame': 'four months', 'description': 'Questionnaire for parents to report symptoms of non-IgE mediated food allergy'}, {'measure': 'Exploratory: Peanut sensitization 12 months', 'timeFrame': '12 months', 'description': 'Questionnaire for parents to report signs of peanut allergy'}, {'measure': 'Mechanistic: antigen level', 'timeFrame': 'four months', 'description': 'Measure PN and egg antigen levels in house dust and human milk'}, {'measure': 'Mechanistic: IgG levels', 'timeFrame': 'four months', 'description': 'Quantify PN- and egg-specific IgG antibody levels in maternal serum and human milk.'}, {'measure': 'Mechanistic: T cell', 'timeFrame': 'four months', 'description': 'Phenotype infant T cell populations in cord blood and infant blood.'}], 'primaryOutcomes': [{'measure': 'Egg or peanut sensitization', 'timeFrame': 'four months', 'description': 'Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).'}], 'secondaryOutcomes': [{'measure': 'Peanut and egg specific IgG and IgG4', 'timeFrame': 'four months', 'description': 'Levels of infant peanut and egg specific IgG and IgG4'}, {'measure': 'Antibodies in maternal blood', 'timeFrame': 'four months', 'description': 'Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.'}, {'measure': 'Egg allergy', 'timeFrame': '12 months', 'description': 'Questionnaire for parents to report any signs of egg allergy in their child.'}, {'measure': 'Egg and peanut specific IgE', 'timeFrame': 'four months', 'description': 'Measure levels of infant egg- and peanut-specific IgE.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergy and Immunology', 'Peanut and Nut Allergy', 'Egg Allergy', 'Food Allergy in Infants', 'Food Allergy Peanut']}, 'descriptionModule': {'briefSummary': 'Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.', 'detailedDescription': "The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'To understand the mechanisms whereby maternal diet either positively or negatively affects the development of their infant from the womb through the first few months of life, it is necessary to recruit healthy pregnant women.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n• o Subject must be able to understand and provide informed consent.\n\n* English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)\n* Maternal consent must be provided for infants.\n* Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.\n* Self-reported at time of enrollment:\n\n * no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester\n * carrying a fetus with a first-degree relative (i.e., mother, father, full sibling) with any self-reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy).\n* Intend to give their infant their own breast milk for more than 3 months.\n* Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.\n* Willing to be randomized to consumption or avoidance diet.\n* Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.\n\nExclusion Criteria:\n\n* Inability or unwillingness of subject to give written informed consent or comply with study protocol.\n* Known history of renal/liver/cardiac insufficiency in the mother or infant.\n* Pregnant women with PN or egg allergy.\n* Pregnant women who refuse to eat PN (or peanut products) and/or eggs.\n* Physician diagnosed immunodeficiency in the mother or infant.\n* Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.\n* Past or current medical problems or findings from medical history that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study."}, 'identificationModule': {'nctId': 'NCT06260956', 'acronym': 'ESCAPE', 'briefTitle': "Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg", 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': "Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg", 'orgStudyIdInfo': {'id': 'U01-ROC-001'}, 'secondaryIdInfos': [{'id': '1U01AI173032', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI173032', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 Consumption', 'description': 'Subjects must consume peanuts and peanut products and egg and egg products.', 'interventionNames': ['Behavioral: Consumption']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Avoidance', 'description': 'Subjects must avoid eating peanuts and peanut products and egg and egg products.', 'interventionNames': ['Behavioral: Avoidance']}], 'interventions': [{'name': 'Consumption', 'type': 'BEHAVIORAL', 'description': 'Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.', 'armGroupLabels': ['Arm 1 Consumption']}, {'name': 'Avoidance', 'type': 'BEHAVIORAL', 'description': 'Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.', 'armGroupLabels': ['Arm 2 Avoidance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kirsi Jarvinen-Seppo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Allison W Leadley, MPH', 'role': 'CONTACT', 'email': 'allison_leadley@urmc.rochester.edu', 'phone': '585-275-4640'}, {'name': 'Leanna Twohig, MS', 'role': 'CONTACT', 'email': 'Leanna_Twohig@urmc.rochester.edu', 'phone': '585-275-4640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Per NIH policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Pediatric Allergy and Immunology', 'investigatorFullName': 'Kirsi Jarvinen-Seppo', 'investigatorAffiliation': 'University of Rochester'}}}}