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

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ClinicalTrials.gov Identifier: NCT03172676

Recruitment Status : Unknown

Verified December 2019 by Mary Makram Kamel, Assiut University.
Recruitment status was: Recruiting

First Posted : June 1, 2017

Last Update Posted : January 3, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Mary Makram Kamel, Assiut University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenia	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	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	75 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
Actual Study Start Date :	January 1, 2020
Estimated Primary Completion Date :	June 1, 2020
Estimated Study Completion Date :	August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia Thrombotic thrombocytopenic purpura

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Helicobacter pylori negative patients 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.
Active Comparator: Helicobacter pylori positive patients with intervention 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).	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. Drug: 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. Drug: 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.
No Intervention: Helicobacter pylori positive patients without intervention 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

Outcome Measures

Primary Outcome Measures :

effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	1 Year to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months
age <18 years .
diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL .
Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .

exclusion criteria:

Patients with acute immune thrombocytopenic purpura . .
age >18 years.
thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172676

Contacts

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Contact: Fahim Mohamed, MD	00201002500073	fahim.osman@med.au.edu.eg
Contact: Mervat Amin, MD	00201142606221	mamuosif2002@gmail.com

Locations

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Egypt
Assiut Medical School	Recruiting
Assiut, Egypt, 71511
Contact: mary makram, MA 020012018964133 marymakram142@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

Publications:

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. doi: 10.1007/s00431-006-0344-4. Epub 2006 Nov 29. No abstract available.

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.

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.

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Responsible Party:	Mary Makram Kamel, principal investigator, Assiut University
ClinicalTrials.gov Identifier:	NCT03172676
Other Study ID Numbers:	ITPHP
First Posted:	June 1, 2017 Key Record Dates
Last Update Posted:	January 3, 2020
Last Verified:	December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Thrombocytopenia Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies Hemorrhagic Disorders	Autoimmune Diseases Immune System Diseases Amoxicillin Clarithromycin Proton Pump Inhibitors Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

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