Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
NCT ID: NCT01026350
Last Updated: 2009-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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study group
colostrum enriched with anti flu antibodies
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.
Interventions
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colostrum enriched with anti flu antibodies
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Men \> 18 years.
* Ability and willingness of subject to provide informed consent
* Screening tests' results within 15% of normal values
Exclusion Criteria
* Continuous use of the following medications for more than 3 days within 30 days of study entry:
* Immunosuppressives
* Immune modulators
* Systemic glucocorticoids
* Anti-neoplastic agents
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
* Subjects with a clinically significant infectious, immune mediated or malignant disease
* Subjects with anemia (Hb \<10.5 gm/dl)
* Subjects with thrombocytopenia (platelets \<100K/µl)
* Subjects with lymphopenia (absolute lymphocyte count \<0.7)
* Subjects who were previously vaccinated against flu.
* Subject who received any vaccination within the last 6 months
18 Years
60 Years
MALE
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Immuron Limited
Locations
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Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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tomer adar, md
Role: primary
References
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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.
Other Identifiers
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4811344-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id