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

• ClinicalTrials.gov Identifier: NCT03172676
• Recruitment Status: Recruiting
• First Posted: June 1, 2017
• Last Update Posted: January 3, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mary Makram Kamel, Assiut University

Tracking Information

• First Submitted Date: May 26, 2017
• First Posted Date: June 1, 2017
• Last Update Posted Date: January 3, 2020
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 30, 2017)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Immune 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.
• 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.

Study Arms

• 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).
  Interventions:

  • 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
• 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

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. Epub 2006 Nov 29.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 30, 2017): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2020
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Fahim Mohamed, MD; 00201002500073; fahim.osman@med.au.edu.eg

Contact: Mervat Amin, MD; 00201142606221; mamuosif2002@gmail.com

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03172676
• Other Study ID Numbers: ITPHP
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Mary Makram Kamel, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: December 2019