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

NCT03172676 | Unknown Phase 4

• 1 other identifier: ITPHP
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Helicobacter pylori negative patients

NO INTERVENTION

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.

Helicobacter pylori positive patients with intervention

ACTIVE COMPARATOR

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.; 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

Helicobacter pylori positive patients without intervention

NO 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

Interventions

Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days. DRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.

Helicobacter pylori positive patients with intervention

Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. DRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.

Helicobacter pylori positive patients with intervention

Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month DRUG

chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.

Helicobacter pylori positive patients with intervention

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Medical School

Asyut, 71511, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 17136353 BACKGROUND

• 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.

  PMID: 28071659 BACKGROUND

• 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.

  PMID: 19301380 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Amoxicillin; Clarithromycin; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Fahim Mohamed, MD

CONTACT

00201002500073; fahim.osman@med.au.edu.eg

Mervat Amin, MD

CONTACT

00201142606221; mamuosif2002@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 1, 2017
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: August 30, 2020
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

EG (1)