Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases
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|ClinicalTrials.gov Identifier: NCT01934764|
Recruitment Status : Unknown
Verified August 2013 by Assy Nimer, Ziv Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 4, 2013
Last Update Posted : September 4, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
- Biotin level Test [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934764
|Contact: Nimer Assy, MDfirstname.lastname@example.org|
|Ziv Medical Center||Not yet recruiting|
|Safed, Israel, 13100|
|Contact: Nimer Assy, MD +972-4-6826442 email@example.com|