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

Influenza Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01026350
• Other study ID #: 4811344-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 3, 2009
• Last updated: December 3, 2009
• Start date: January 2010

Study information

• Verified date: November 2009
• Source: Hadassah Medical Organization
• Contact: tomer adar, MD
• Phone: 972-2-6778511
• Email: tomerad[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alterations in immune response to flu antigen		during and after administration of colostrum enriched with anti flu antibodies	No