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NCT Number: NCT00467571

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.

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Key information

Conditions

Chronic Idiopathic Thrombocytopenic Purpura Helicobacter Pylori Infection

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lansoprazole, clarithromycin, amoxycillin

Drug

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

Other names: lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamox

Primary outcomes

  1. platelet count

    Time frame: 6 months

Secondary outcomes

  1. platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)

    Time frame: 6 months

  2. platelet count

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Ramathibodi Hospital

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 30, 2007
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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