Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Helicobacter Pylori Infection Clinical Trial

Official title:

Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467571
• Other study ID #: ID11-48-20
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2007
• Last updated: May 1, 2013
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2008
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Thrombocytopenic Purpura
• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet count		6 months	No
Secondary	platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)		6 months	No
Secondary	platelet count		6 months	No