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

• Conditions: Effects Toxics

• Registration Number: NCT03163147
• Lead Sponsor: Assiut University

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

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 Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-22
• Last Update Posted: 2017-05-22
• Study Start: 2017-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of primary thrombocytopenic patients with helicobacter pylori infection who recieved its treatment and improved clinically and laboratory.	one year