Clinical trial NCT03163147: The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients
Official title: The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients Not Respond on Steroid Therapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effects Toxics
Keywords: frequency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: . Detect the frequency of H pylori infection in patients diagnosed itp not respond on steroid therapy 2. Detect the effect of H pylori in those patients

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% .

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of primary thrombocytopenic patients with helicobacter pylori infection who recieved its treatment and improved clinically and laboratory.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: