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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03172676
• Other study ID #: ITPHP
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

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