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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03172676
Other study ID # ITPHP
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2020
Est. completion date August 30, 2020

Study information

Verified date December 2019
Source Assiut University
Contact Fahim Mohamed, MD
Phone 00201002500073
Email fahim.osman@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date August 30, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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 will receive Amoxicillin for 14 days.
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 will receive Clarithromycin for 14 days.
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 will receive proton pump inhibitor for 1 month.

Locations

Country Name City State
Egypt Assiut Medical School Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10. Erratum in: Am J Gastroenterol. 2018 Jul;113(7):1102. — View Citation

Loffredo G, Marzano MG, Migliorati R, Miele E, Menna F, Poggi V, Staiano A. The relationship between immune thrombocytopenic purpura and Helicobacter pylori infection in children: where is the truth? Eur J Pediatr. 2007 Oct;166(10):1067-8. Epub 2006 Nov 29. — View Citation

Treepongkaruna S, Sirachainan N, Kanjanapongkul S, Winaichatsak A, Sirithorn S, Sumritsopak R, Chuansumrit A. Absence of platelet recovery following Helicobacter pylori eradication in childhood chronic idiopathic thrombocytopenic purpura: a multi-center randomized controlled trial. Pediatr Blood Cancer. 2009 Jul;53(1):72-7. doi: 10.1002/pbc.21991. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
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