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

Phase 4

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

• Registration Number: NCT03172676
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-31
• Study Start: 2020-01-01
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helicobacter pylori positive patients with intervention	Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month	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).
Helicobacter pylori positive patients with intervention	Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.	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).
Helicobacter pylori positive patients with intervention	Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.	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).

Primary Outcome Measures

Name	Time	Method
effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients	6 months	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.

Trial Locations

Locations (1)

Assiut Medical School; 🇪🇬 Assiut, Egypt