Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Study Overview
=================
Brief Summary
-----------------
Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.

Detailed Description
-----------------
Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.

Official Title
-----------------
Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Conditions
-----------------
Chronic Idiopathic Thrombocytopenic Purpura, Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: lansoprazole, clarithromycin, amoxycillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes. 13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection. Exclusion Criteria: Patients who had a previous treatment for H. pylori infection. Patients require prednisolone more than 0.5 mg/kg/day

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Drug: lansoprazole, clarithromycin, amoxycillin | Drug: lansoprazole, clarithromycin, amoxycillin<br>* lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days<br>* Other names: Amoxycillin or Ibiamox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet count |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori) |  | 6 months | 
| platelet count |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet