A Phase 4 interventional study of lansoprazole, clarithromycin, amoxycillin in Chronic Idiopathic Thrombocytopenic Purpura and Helicobacter Pylori Infection, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 26 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Patients who had a previous treatment for H. pylori infection.
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
Also known as: lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamox
platelet count
Time frame: 6 months
platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)
Time frame: 6 months
platelet count
Time frame: 6 months
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Mahidol University