Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

Assiut University75 enrolled

Overview

Thrombocytopenia refers to a reduction in platelet count to (\<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia

Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia

Interventions

Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.DRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.

Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.DRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.

Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 monthDRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. chronic immune thrombocytopenic purpura patients who still have thrombocytopenia \> 12 months 2. age \<18 years . 3. diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count \<100×103/μL . 4. Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura . exclusion criteria: 1. Patients with acute immune thrombocytopenic purpura . . 2. age \>18 years. 3. thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis. 4. previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.

Locations (1)

Assiut Medical School

Asyut, Egypt

RECRUITING

Outcomes

Primary Outcomes

effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients

platelet counts will be measured at the start of the study ,before the starting of the interventions, and after 6 months. platelet response will be classified as: 1-complete response: platelet count\> 150 × 109/L , 2-partial response: platelet count : 50-150 × 109/L , no response: platelet count \< 50 × 109/L.

Time frame: 6 months

Central Contacts

Fahim Mohamed, MD

CONTACT

00201002500073 fahim.osman@med.au.edu.eg

Mervat Amin, MD

CONTACT

00201142606221 mamuosif2002@gmail.com

Data from ClinicalTrials.gov

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