Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
1 other identifier
interventional
10
1 country
1
Brief Summary
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedDecember 4, 2009
November 1, 2009
1 year
December 3, 2009
December 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
alterations in immune response to flu antigen
during and after administration of colostrum enriched with anti flu antibodies
Study Arms (1)
study group
EXPERIMENTALInterventions
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
You may qualify if:
- Healthy male volunteers ages 18-60
- 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
You may not qualify if:
- Female
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Hebrew University Medical Center
Jerusalem, POB 12000, Israel
Related Publications (1)
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.
PMID: 18602824BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 3, 2009
First Posted
December 4, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Last Updated
December 4, 2009
Record last verified: 2009-11