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

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
colostrum enriched with anti flu antibodies
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring modulating immune response to flu antigen

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hadassah Hebrew University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

Outcomes

Primary Outcome Measures

alterations in immune response to flu antigen

Secondary Outcome Measures

Full Information

First Posted
December 3, 2009
Last Updated
December 3, 2009
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01026350
Brief Title
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
modulating immune response to flu antigen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
colostrum enriched with anti flu antibodies
Intervention Description
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 Measure Information:
Title
alterations in immune response to flu antigen
Time Frame
during and after administration of colostrum enriched with anti flu antibodies

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tomer adar, MD
Phone
972-2-6778511
Email
tomerad@hadassah.org.il
Facility Information:
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
POB 12000
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tomer adar, md
Phone
972-2-6778511
Email
tomerad@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Tomer Adar, MD
First Name & Middle Initial & Last Name & Degree
Gadi Lalazar, MD
First Name & Middle Initial & Last Name & Degree
Mizrahi Mair, MD
First Name & Middle Initial & Last Name & Degree
Yuval Horowitz, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18602824
Citation
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.
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Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

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