NCT07150286

Helicobacter Pylori Eradication Therapy for Immune Thrombocytopenia (ITP) Patients in Iraq

Assessment of Hematological Effect of H.Pylori and H.Pylori Eradication Therapy Among a Sample of Iraqi ITP Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the effect of treating Helicobacter pylori infection on platelet counts in patients with immune thrombocytopenia (ITP). ITP is a condition in which the body's immune system attacks its own platelets, leading to an increased risk of bleeding and bruising. Some studies have suggested that removing H. pylori infection may help improve platelet counts in certain patients with ITP. In this study, 100 patients with ITP will be enrolled at hematology centers in Baghdad. Patients will be tested for H. pylori infection using stool antigen testing. Those who are positive will receive a 14-day antibiotic treatment (levofloxacin-based therapy) to eradicate the infection. Platelet counts will be measured before and after therapy to determine whether successful eradication improves platelet levels. The findings from this study may help provide new treatment options for ITP patients and give doctors in Iraq more evidence about how H. pylori infection affects blood disorders.

Detailed description

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelet counts and increased bleeding risk. Several studies have suggested a link between Helicobacter pylori infection and platelet recovery following eradication therapy, though results differ across regions and populations. This investigator-initiated, prospective study aims to assess the hematological effect of H. pylori eradication in Iraqi patients with ITP. A total of 100 patients will be recruited at two hematology centers in Baghdad. Patients will undergo stool antigen testing to determine H. pylori status. The study is divided into two phases: Phase 1: Observational cross-sectional analysis of ITP patients who are H. pylori negative. Phase 2: Interventional, prospective, open-label evaluation of ITP patients who are H. pylori positive compared with H. pylori negative controls. Patients testing positive for H. pylori will receive a 14-day levofloxacin-based triple therapy regimen consistent with current American College of Gastroenterology (ACG) guidelines. Platelet counts will be measured at baseline and four weeks after therapy completion. Outcomes will focus on hematological response to eradication, with secondary analysis comparing platelet recovery between H. pylori positive and negative patients. This study is the first in Iraq to evaluate the impact of salvage therapy for H. pylori eradication in ITP patients. The results may provide novel insights into regional differences in treatment response and inform future clinical practice guidelines for managing ITP.

Conditions

• Immune Thrombocytopenic Purpura
• HELICOBACTER PYLORI INFECTIONS

Interventions

Type	Name	Description
DRUG	Levofloxacin-Based H. pylori Eradication Therapy	This intervention consists of a 14-day levofloxacin-based triple therapy regimen for Helicobacter pylori eradication in ITP patients. The regimen follows current ACG guidelines and typically includes: Levofloxacin - antibiotic targeting H. pylori Amoxicillin - antibiotic used in combination for enhanced efficacy Proton Pump Inhibitor (PPI) - to reduce stomach acid and improve antibiotic effectiveness Patients will receive the full 14-day course, and platelet counts will be measured at baseline and four weeks post-therapy to assess hematological response. This intervention is unique to H. pylori-positive ITP patients in this study and is not administered to H. pylori-negative patients.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-31
• Completion: 2025-04-01
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: Iraq