Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

NCT01934764 | Unknown

• 1 other identifier: 0027-13-ziv
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Disease

Outcome Measures

Primary Outcomes (1)

• Biotin level Test

  Baseline

Study Arms (1)

autoimmune disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with autoimmune disease

You may qualify if:

• Freely given informed consent
• Autoimmune disease

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Nimer Assy, MD

CONTACT

+972-4-6828442; assy.n@ziv.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

IL (1)