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Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Primary Purpose

Chronic Idiopathic Thrombocytopenic Purpura, Helicobacter Pylori Infection

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

lansoprazole, clarithromycin, amoxycillin

About this trial

This is an interventional treatment trial for Chronic Idiopathic Thrombocytopenic Purpura focused on measuring chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Drug: lansoprazole, clarithromycin, amoxycillin

Outcomes

Primary Outcome Measures

platelet count

Secondary Outcome Measures

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

platelet count

Full Information

NCT ID

NCT00467571

First Posted

April 27, 2007

Last Updated

May 1, 2013

Sponsor

Mahidol University

Collaborators

Ramathibodi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00467571

Brief Title

Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Official Title

Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

Ramathibodi Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Idiopathic Thrombocytopenic Purpura, Helicobacter Pylori Infection

Keywords

chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Drug: lansoprazole, clarithromycin, amoxycillin

Intervention Type

Drug

Intervention Name(s)

lansoprazole, clarithromycin, amoxycillin

Other Intervention Name(s)

lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamox

Intervention Description

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

Primary Outcome Measure Information:

Title

platelet count

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

platelet count

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suporn Treepongkaruna, M.D.

Organizational Affiliation

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

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