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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
Information provided by:

December 3, 2009
December 4, 2009
December 4, 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 ]
Same as current
No Changes Posted
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Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
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Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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. doi: 10.1016/j.jnutbio.2008.04.002. Epub 2008 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Immuron Limited
Hadassah Medical Organization
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Hadassah Medical Organization
November 2009

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