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Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01026350
Recruitment Status : Unknown
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2009
Last Update Posted : December 4, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.

Condition or disease Intervention/treatment Phase
Influenza Dietary Supplement: colostrum enriched with anti flu antibodies Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2010
Estimated Primary Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: study group Dietary Supplement: 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.



Primary Outcome Measures :
  1. alterations in immune response to flu antigen [ Time Frame: during and after administration of colostrum enriched with anti flu antibodies ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026350


Contacts
Contact: tomer adar, MD 972-2-6778511 tomerad@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, POB 12000
Contact: tomer adar, md    972-2-6778511    tomerad@hadassah.org.il   
Principal Investigator: Tomer Adar, MD         
Sub-Investigator: Gadi Lalazar, MD         
Sub-Investigator: Mizrahi Mair, MD         
Sub-Investigator: Yuval Horowitz, MD         
Sponsors and Collaborators
Hadassah Medical Organization

Publications:
Responsible Party: Immuron Limited
ClinicalTrials.gov Identifier: NCT01026350     History of Changes
Other Study ID Numbers: 4811344-HMO-CTIL
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: November 2009

Keywords provided by Hadassah Medical Organization:
modulating immune response to flu antigen

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs