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Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

Sponsor
Ziv Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01934764
Collaborator
(none)
60
Enrollment
1
Location

Study Details

Study Description

Brief 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:

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

  2. 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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2013
    Anticipated Primary Completion Date :
    Sep 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    autoimmune disease

    Outcome Measures

    Primary Outcome Measures

    1. Biotin level Test [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Freely given informed consent

    • Autoimmune disease

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ziv Medical Center Safed Israel 13100

    Sponsors and Collaborators

    • Ziv Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assy Nimer, MD, Ziv Hospital
    ClinicalTrials.gov Identifier:
    NCT01934764
    Other Study ID Numbers:
    • 0027-13-ziv
    First Posted:
    Sep 4, 2013
    Last Update Posted:
    Sep 4, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Autoimmune Diseases

    Study Results

    No Results Posted as of Sep 4, 2013