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| Sponsor: | Mahidol University |
|---|---|
| Collaborator: |
Ramathibodi Hospital |
| Information provided by: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT00467571 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Idiopathic Thrombocytopenic Purpura Helicobacter Pylori Infection |
Drug: lansoprazole, clarithromycin, amoxycillin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura |
| Estimated Enrollment: | 26 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
Drug: lansoprazole, clarithromycin, amoxycillin
|
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
|
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| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who had a previous treatment for H. pylori infection.
Contacts and Locations| Contact: Suporn Treepongkaruna, M.D. | 66 2201 1446 | rastp@mahidol.ac.th |
| Contact: Nongnut Sirachainan, M.D. | 66 22011748 | rasrb@mahidol.ac.th |
| Thailand | |
| Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Recruiting |
| Bangkok, Thailand, 10400 | |
| Contact: Suporn Treepongkaruna, M.D. 66 2201 1446 rastp@mahidol.ac.th | |
| Contact: Nongnut Sirachainan, M.D. 66 2201 1748 rasrb@mahidol.ac.th | |
| Principal Investigator: Suporn Treepongkaruna, M.D. | |
| Principal Investigator: | Suporn Treepongkaruna, M.D. | Faculty of Medicine, Ramathibodi Hospital, Mahidol University |
More Information
| Responsible Party: | Mahidol University ( Suporn Treepongkaruna ) |
| Study ID Numbers: | ID11-48-20 |
| Study First Received: | April 27, 2007 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00467571 History of Changes |
| Health Authority: | Thailand: Ethical Committee |
|
chronic idiopathic thrombocytopenic purpura Helicobacter pylori infection platelet |
|
Skin Manifestations Communicable Diseases Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Infection Purpura, Thrombocytopenic Signs and Symptoms Clarithromycin Anti-Bacterial Agents Hemorrhagic Disorders Thrombocytopenia Therapeutic Uses Anti-Ulcer Agents |
Purpura Amoxicillin Autoimmune Diseases Immune System Diseases Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Protein Synthesis Inhibitors Purpura, Thrombocytopenic, Idiopathic Lansoprazole |
