Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital

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:

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
Autoimmune Disease

Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

autoimmune disease

Primary Outcome Measures :
  1. Biotin level Test [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
People with autoimmune disease

Inclusion Criteria:

  • Freely given informed consent
  • Autoimmune disease

Exclusion Criteria:

Information from the National Library of Medicine

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 identifier (NCT number): NCT01934764

Contact: Nimer Assy, MD +972-4-6828442

Ziv Medical Center Not yet recruiting
Safed, Israel, 13100
Contact: Nimer Assy, MD    +972-4-6826442   
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Assy Nimer, MD, Ziv Hospital Identifier: NCT01934764     History of Changes
Other Study ID Numbers: 0027-13-ziv
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases