Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01730352

Enrollment

100

Registered

2012-11-21

Start date

2008-10-31

Completion date

2012-03-31

Last updated

2012-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection, Immune Thrombocytopenic Purpura

Keywords

immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents

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.

Interventions

DRUGH. pylori triple therapy

Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
platelet response	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026