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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01934764
Other study ID # 0027-13-ziv
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 29, 2013
Last updated September 3, 2013
Start date September 2013

Study information

Verified date August 2013
Source Ziv Hospital
Contact Nimer Assy, MD
Phone +972-4-6828442
Email assy.n@ziv.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. In this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied:

A. Assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease.

B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker.

Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E. Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease.

Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased in patients with active autoimmune liver diseases.

Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease.

Probable implications to Medicine: Identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Freely given informed consent

- Autoimmune disease

Exclusion Criteria:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Ziv Medical Center Safed

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biotin level Test Baseline Yes
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