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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01026350
First received: December 3, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

December 3, 2009
December 3, 2009
January 2010
January 2011   (final data collection date for primary outcome measure)
alterations in immune response to flu antigen [ Time Frame: during and after administration of colostrum enriched with anti flu antibodies ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
Not Provided

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
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.
Experimental: study group
Intervention: Dietary Supplement: colostrum enriched with anti flu antibodies
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. Epub 2008 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
Yes
Contact: tomer adar, MD 972-2-6778511 tomerad@hadassah.org.il
Israel
 
NCT01026350
4811344-HMO-CTIL
Not Provided
Immuron Limited
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP