Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Federal University of São Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Helicobacter Pylori Infection; Immune Thrombocytopenic Purpura

Treatments: Drug: H. pylori triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01730352

08/56706-0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: Under 20 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

H. pylori no treatment

No Intervention group

Description:

Observational group, with clinical and platelet count follow-up

H. pylori triple therapy

Experimental group

Description:

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.

Treatment:

Drug: H. pylori triple therapy