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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: December 3, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.

Condition Intervention Phase
Influenza Dietary Supplement: colostrum enriched with anti flu antibodies Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01026350

Contact: tomer adar, MD 972-2-6778511

Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, POB 12000
Contact: tomer adar, md    972-2-6778511   
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
  More Information

Responsible Party: Immuron Limited Identifier: NCT01026350     History of Changes
Other Study ID Numbers: 4811344-HMO-CTIL
Study First Received: December 3, 2009
Last Updated: December 3, 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
Immunologic Factors
Physiological Effects of Drugs processed this record on August 21, 2017