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

Phase 1

• Conditions: Influenza
• Interventions: Dietary Supplement: colostrum enriched with anti flu antibodies

• Registration Number: NCT01026350
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Last Update Submitted: 2009-12-03
• Study First Posted: 2009-12-04
• Last Update Posted: 2009-12-04
• Study Start: 2010-01
• Primary Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	colostrum enriched with anti flu antibodies	-

Primary Outcome Measures

Name	Time	Method
alterations in immune response to flu antigen	during and after administration of colostrum enriched with anti flu antibodies

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel