Immune Thrombocytopenia
Conditions
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.
Interventions
DRUGAmoxicillin 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 will receive Amoxicillin for 14 days.
DRUGClarithromycin 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 will receive Clarithromycin for 14 days.
DRUGProton 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 will receive proton pump inhibitor for 1 month.
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactFahim Mohamed, MD
Backup ContactMervat Amin, MD
Outcome results
None listed