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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 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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Immuron Limited
ClinicalTrials.gov Identifier: NCT01026350     History of Changes
Other Study ID Numbers: 4811344-HMO-CTIL
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: Israel: Ministry of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013