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Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

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ClinicalTrials.gov Identifier: NCT00467571
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
Ramathibodi Hospital
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Thrombocytopenic Purpura Helicobacter Pylori Infection Drug: lansoprazole, clarithromycin, amoxycillin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Study Start Date : March 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
Experimental: I
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
Other Names:
  • lansoprazole or Prevacid
  • clarithromycin or Klacid
  • Amoxycillin or Ibiamox




Primary Outcome Measures :
  1. platelet count [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467571


Locations
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Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Ramathibodi Hospital
Investigators
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Principal Investigator: Suporn Treepongkaruna, M.D. Faculty of Medicine, Ramathibodi Hospital, Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT00467571     History of Changes
Other Study ID Numbers: ID11-48-20
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: September 2008
Keywords provided by Mahidol University:
chronic idiopathic thrombocytopenic purpura
Helicobacter pylori infection
platelet
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Hemorrhagic Disorders
Autoimmune Diseases
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors