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Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

M

Mahidol University

Status and phase

Completed
Phase 4

Conditions

Chronic Idiopathic Thrombocytopenic Purpura
Helicobacter Pylori Infection

Treatments

Drug: lansoprazole, clarithromycin, amoxycillin

Study type

Interventional

Funder types

Other

Identifiers

NCT00467571
ID11-48-20

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 1 patient group

I
Experimental group
Description:
Drug: lansoprazole, clarithromycin, amoxycillin
Treatment:
Drug: lansoprazole, clarithromycin, amoxycillin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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