Official Title: “Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • Drug: lansoprazole, clarithromycin, amoxycillin

Primary Measures

• platelet count
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)
  • Time Frame: 6 months
    Safety Issue?: No
• platelet count
  • Time Frame: 6 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mahidol University

Overall Clinical Trial Officials and Contacts

Suporn Treepongkaruna, M.D. Principal Investigator Faculty of Medicine, Ramathibodi Hospital, Mahidol University  

Overall Contact: Suporn Treepongkaruna, M.D. 66 2201 1446 rastp@mahidol.ac.th

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00467571

Study ID Number: ID11-48-20

ClinicalTrials.gov Identifier: NCT00467571

Health Authority: Thailand: Ethical Committee