Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Idiopathic Thrombocytopenic Purpura; Helicobacter Pylori Infection
Intervention: lansoprazole, clarithromycin, amoxycillin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Suporn Treepongkaruna, M.D., Principal Investigator, Affiliation: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Overall contact:
Suporn Treepongkaruna, M.D., Phone: 66 2201 1446, Email: rastp@mahidol.ac.th
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.
Clinical Details
Official title: Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: platelet count
Secondary outcome: platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)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.
Eligibility
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Suporn Treepongkaruna, M.D., Phone: 66 2201 1446, Email: rastp@mahidol.ac.th
Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand; Recruiting
Suporn Treepongkaruna, M.D., Phone: 66 2201 1446, Email: rastp@mahidol.ac.th
Nongnut Sirachainan, M.D., Phone: 66 2201 1748, Email: rasrb@mahidol.ac.th
Suporn Treepongkaruna, M.D., Principal Investigator
Additional Information
Starting date: March 2006
Ending date: December 2008
Last updated: September 16, 2008
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