Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura - Full Text View

Sponsors and Collaborators:	Mahidol University 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

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Lansoprazole

U.S. FDA Resources

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

Further study details as provided by Mahidol University:

Primary Outcome Measures:

platelet count [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
platelet count [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

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.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467571

Contacts

Contact: Suporn Treepongkaruna, M.D.	66 2201 1446	rastp@mahidol.ac.th
Contact: Nongnut Sirachainan, M.D.	66 22011748	rasrb@mahidol.ac.th

Locations

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.

Sponsors and Collaborators

Mahidol University

Ramathibodi Hospital

Investigators

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
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

chronic idiopathic thrombocytopenic purpura
Helicobacter pylori infection
platelet

Study placed in the following topic categories:

Purpura
Amoxicillin
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic

Clarithromycin
Signs and Symptoms
Thrombocytopathy
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic
Lansoprazole

Additional relevant MeSH terms:

Communicable Diseases
Skin Manifestations
Anti-Infective Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Enzyme Inhibitors

Infection
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Therapeutic Uses
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on January 15, 2009