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

H

Hadassah Medical Center

Status and phase

Unknown
Phase 1

Conditions

Influenza

Treatments

Dietary Supplement: colostrum enriched with anti flu antibodies

Study type

Interventional

Funder types

Other

Identifiers

NCT01026350
4811344-HMO-CTIL

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

study group
Experimental group
Treatment:
Dietary Supplement: colostrum enriched with anti flu antibodies

Trial contacts and locations

1

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Central trial contact

tomer adar, MD

Data sourced from clinicaltrials.gov

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