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Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Assy Nimer, Ziv Hospital.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital Identifier:
First received: August 29, 2013
Last updated: September 3, 2013
Last verified: August 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.

Autoimmune Disease

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Assy Nimer, Ziv Hospital:

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

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
autoimmune disease


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Assy Nimer, MD, Ziv Hospital Identifier: NCT01934764     History of Changes
Other Study ID Numbers: 0027-13-ziv
Study First Received: August 29, 2013
Last Updated: September 3, 2013

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases processed this record on September 19, 2017