Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00467571

Enrollment

Registered

2007-04-30

Start date

2006-03-31

Completion date

2008-12-31

Last updated

2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Thrombocytopenic Purpura, Helicobacter Pylori Infection

Keywords

chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet

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.

Interventions

DRUGlansoprazole, 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
platelet count	6 months

Secondary

Measure	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026