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

Primary Purpose

Immune Thrombocytopenia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Helicobacter pylori negative patients

Helicobacter pylori positive patients with intervention

Helicobacter pylori positive patients without intervention

Arm Description

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.

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2017
Last Updated
December 31, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03172676
Brief Title
Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura
Official Title
Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Helicobacter pylori negative patients
Arm Type
No Intervention
Arm Description
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.
Arm Title
Helicobacter pylori positive patients with intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Helicobacter pylori positive patients without intervention
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
Intervention Description
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
Intervention Description
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.
Intervention Type
Drug
Intervention Name(s)
Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
Intervention Description
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.
Primary Outcome Measure Information:
Title
effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahim Mohamed, MD
Phone
00201002500073
Email
fahim.osman@med.au.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mervat Amin, MD
Phone
00201142606221
Email
mamuosif2002@gmail.com
Facility Information:
Facility Name
Assiut Medical School
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mary makram, MA
Phone
020012018964133
Email
marymakram142@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17136353
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. doi: 10.1007/s00431-006-0344-4. Epub 2006 Nov 29. No abstract available.
Results Reference
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PubMed Identifier
28071659
Citation
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.
Results Reference
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PubMed Identifier
19301380
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.
Results Reference
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Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

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