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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Immune Thrombocytopenia

Treatments: Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month; Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.; Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.

Study type: Interventional

Funder types: Other

Identifiers

NCT03172676

ITPHP

Details and patient eligibility

About

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

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Helicobacter pylori negative patients

No Intervention group

Description:

chronic immune thrombocytopenic purpura patients who will be diagnosed negative for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients.

Helicobacter pylori positive patients with intervention

Active Comparator group

Description:

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).

Treatment:

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

Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month

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

Helicobacter pylori positive patients without intervention

No Intervention group

Description:

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will not receive treatment of Helicobacter pylori during the study,these patient group will receive treatment of Helicobacter pylori after the end of the study