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The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03163147
Collaborator
(none)
100
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP .

Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy . the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP.

    Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy. the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders The recent entry of Helicobacter pylori to the growing list of etiologies of itp has stirred much interest. . The relationship between H pylori infection and immune thrombocytopenia (ITP) is less clear .

    However, among patients with H.pylori-associated ITP, a significant percentage achieve lasting remission after eradication of H.pylori .

    H.pylori can be readily detected by non invasive methods, the C-urea breath test and antigen detection in stools are considered to be the most accurate, with both sensitivity and specificity in the range of 90% to 95% .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients Not Respond on Steroid Therapy.
    Anticipated Study Start Date :
    Jun 1, 2017
    Anticipated Primary Completion Date :
    Jun 1, 2018
    Anticipated Study Completion Date :
    Jun 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of primary thrombocytopenic patients with helicobacter pylori infection who recieved its treatment and improved clinically and laboratory. [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1.Patients diagnosed ITP and failed on steroid therapy.

    Exclusion Criteria:

    1. Patients with systemic lupus erythromatous

    2. Drug administration

    3. Hepatitis c infection

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reham Badr, Assiut University, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03163147
    Other Study ID Numbers:
    • assiut 5000
    First Posted:
    May 22, 2017
    Last Update Posted:
    May 22, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Reham Badr, Assiut University, Assiut University
    frequency
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of May 22, 2017