Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Phase 4

Completed

• Conditions: Chronic Idiopathic Thrombocytopenic Purpura; Helicobacter Pylori Infection
• Interventions: Drug: lansoprazole, clarithromycin, amoxycillin

• Registration Number: NCT00467571
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Last Update Submitted: 2013-05-01
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	lansoprazole, clarithromycin, amoxycillin	Drug: lansoprazole, clarithromycin, amoxycillin

Primary Outcome Measures

Name	Time	Method
platelet count	6 months

Secondary Outcome Measures

Name	Time	Method
platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)	6 months
platelet count	6 months

Trial Locations

Locations (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand