Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 8:53 PM
Study NCT ID:
NCT01026350
Status:
UNKNOWN
Last Update Posted:
2009-12-04
First Post:
2009-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alterations in immune response to flu antigen', 'timeFrame': 'during and after administration of colostrum enriched with anti flu antibodies'}]}, 'conditionsModule': {'keywords': ['modulating immune response to flu antigen'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '18602824', 'type': 'BACKGROUND', 'citation': 'Kim JH, Jung WS, Choi NJ, Kim DO, Shin DH, Kim YJ. Health-promoting effects of bovine colostrum in Type 2 diabetic patients can reduce blood glucose, cholesterol, triglyceride and ketones. J Nutr Biochem. 2009 Apr;20(4):298-303. doi: 10.1016/j.jnutbio.2008.04.002. Epub 2008 Jul 7.'}]}, 'descriptionModule': {'briefSummary': "Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male volunteers ages 18-60\n* If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication\n* Men \\> 18 years.\n* Ability and willingness of subject to provide informed consent\n* Screening tests' results within 15% of normal values\n\nExclusion Criteria:\n\n* Female\n* Continuous use of the following medications for more than 3 days within 30 days of study entry:\n* Immunosuppressives\n* Immune modulators\n* Systemic glucocorticoids\n* Anti-neoplastic agents\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.\n* Subjects with a clinically significant infectious, immune mediated or malignant disease\n* Subjects with anemia (Hb \\<10.5 gm/dl)\n* Subjects with thrombocytopenia (platelets \\<100K/µl)\n* Subjects with lymphopenia (absolute lymphocyte count \\<0.7)\n* Subjects who were previously vaccinated against flu.\n* Subject who received any vaccination within the last 6 months"}, 'identificationModule': {'nctId': 'NCT01026350', 'briefTitle': 'Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': '4811344-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'interventionNames': ['Dietary Supplement: colostrum enriched with anti flu antibodies']}], 'interventions': [{'name': 'colostrum enriched with anti flu antibodies', 'type': 'DIETARY_SUPPLEMENT', 'description': 'each volunteer will receive six 1.2 g oral tablets (equivalent to 600 mg of bovine colostrum powder each) once a day for two weeks.', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'POB 12000', 'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'tomer adar, md', 'role': 'CONTACT', 'email': 'tomerad@hadassah.org.il', 'phone': '972-2-6778511'}, {'name': 'Tomer Adar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gadi Lalazar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mizrahi Mair, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuval Horowitz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hadassah Hebrew University Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'tomer adar, MD', 'role': 'CONTACT', 'email': 'tomerad@hadassah.org.il', 'phone': '972-2-6778511'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Immuron Limited', 'oldOrganization': 'Immuron Limited'}}}}