Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Helicobacter Pylori Infection

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Detailed Description

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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.

Conditions

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Chronic Idiopathic Thrombocytopenic Purpura Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Drug: lansoprazole, clarithromycin, amoxycillin

Group Type EXPERIMENTAL

lansoprazole, clarithromycin, amoxycillin

Intervention Type DRUG

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

Interventions

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lansoprazole, clarithromycin, amoxycillin

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

Intervention Type DRUG

Other Intervention Names

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lansoprazole or Prevacid clarithromycin or Klacid Amoxycillin or Ibiamox

Eligibility Criteria

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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.