Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

Study Overview
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Brief Summary
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Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia

Detailed Description
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Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.

Official Title
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Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
* Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
* Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months age <18 years . diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL . Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura . exclusion criteria: Patients with acute immune thrombocytopenic purpura . . age >18 years. thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis. previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Helicobacter pylori negative patients<br>chronic immune thrombocytopenic purpura patients who will be diagnosed negative for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients. | |
| Active Comparator: Helicobacter pylori positive patients with intervention<br>chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month). | Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.<br>* chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.<br>Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.<br>* chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.<br>Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month<br>* chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.<br>|
| No Intervention: Helicobacter pylori positive patients without intervention<br>chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will not receive treatment of Helicobacter pylori during the study,these patient group will receive treatment of Helicobacter pylori after the end of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients | platelet counts will be measured at the start of the study ,before the starting of the interventions, and after 6 months. platelet response will be classified as: 1-complete response: platelet count> 150 × 109/L , 2-partial response: platelet count : 50-150 × 109/L , no response: platelet count < 50 × 109/L. | 6 months |