InfluenzaPhase 1NCT01026350
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
A Phase 1 study testing colostrum enriched with anti flu antibodies in people with Influenza, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- colostrum enriched with anti flu antibodies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Hebrew University Medical Center
Jerusalem, POB 12000
tomer adar, md, 972-2-6778511, tomerad@hadassah.org.il
Tomer Adar, MD
About this study
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
- Conditions
- Influenza
- Being tested
- colostrum enriched with anti flu antibodies
- Keywords
- modulating immune response to flu antigen
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colostrum enriched with anti flu antibodiesDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Dietary Supplement: colostrum enriched with anti flu antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
alterations in immune response to flu antigen
Measured: during and after administration of colostrum enriched with anti flu antibodies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026350
- Sponsor's protocol ID
- 4811344-HMO-CTIL
- Status last verified
- Nov 2009
- First submitted
- 3 Dec 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
Publications
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.
PubMed 18602824
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01026350
- Acronym / sponsor ID
- 4811344-HMO-CTIL
- Conditions
- Influenza
- Keywords
- modulating immune response to flu antigen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Dietary Supplement: colostrum enriched with anti flu antibodies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Female
- Continuous use of the following medications for more than 3 days within 30 days of study entry:
- Immunosuppressives
- Immune modulators
- Systemic glucocorticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colostrum enriched with anti flu antibodieseach volunteer will receive six 1.2 g oral tablets (equivalent to 600 mg of bovine colostrum powder each) once a day for two weeks. | Dietary supplement | study group |
Primary outcome
alterations in immune response to flu antigen
Time frame: during and after administration of colostrum enriched with anti flu antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
- Background: PubMed 18602824Kim 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing colostrum enriched with anti flu antibodies in people with Influenza, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tomer adar, MD (972-2-6778511, tomerad@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alterations in immune response to flu antigen (time frame: during and after administration of colostrum enriched with anti flu antibodies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01026350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.