Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP.

Detailed Description
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Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP), and there is scientific evidence for the investigation and treatment of this bacterium for adult patients with ITP. However, in children this causal association is not clear, with few published studies.

Official Title
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Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial

Conditions
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Immune Thrombocytopenic Purpura, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: H. pylori triple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of chronic immune thrombocytopenic purpura children and adolescents up to 20 years Exclusion Criteria: known hypersensitivity to any of the drugs recent treatment for H. pylori eradication

Ages Eligible for Study
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Maximum Age: 20 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: H. pylori no treatment<br>Observational group, with clinical and platelet count follow-up | |
| Experimental: H. pylori triple therapy<br>Triple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days. | Drug: H. pylori triple therapy<br>* Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.<br>* Other names: Pyloripac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet response | Responders: Complete Response (CR), persistent elevation of platelet count to >150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents