Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- platelet response
Study Overview
Brief Summary
The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP.
Detailed Description
Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP), and there is scientific evidence for the investigation and treatment of this bacterium for adult patients with ITP. However, in children this causal association is not clear, with few published studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of chronic immune thrombocytopenic purpura
- •children and adolescents up to 20 years
Exclusion Criteria
- •known hypersensitivity to any of the drugs
- •recent treatment for H. pylori eradication
Arms & Interventions
H. pylori triple therapy
Triple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days.
Intervention: H. pylori triple therapy (Drug)
Outcomes
Primary Outcomes
platelet response
Time Frame: 1 year
Responders: Complete Response (CR), persistent elevation of platelet count to \>150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories.
Secondary Outcomes
No secondary outcomes reported
Investigators
Elisabete Kawakami
Professor, PhD MD
Federal University of São Paulo