Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases
Recruitment status was: Not yet recruiting
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.
|Study Design:||Time Perspective: Prospective|
- Biotin level Test [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934764
|Ziv Medical Center|
|Safed, Israel, 13100|