Influenza
Conditions
Keywords
modulating immune response to flu antigen
Brief summary
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
Interventions
DIETARY_SUPPLEMENTcolostrum 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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| alterations in immune response to flu antigen | during and after administration of colostrum enriched with anti flu antibodies |
Countries
Israel
Contacts
Primary Contacttomer adar, MD
Outcome results
None listed