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

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.

Inclusion criteria

• Adults (≥18 years) with a confirmed diagnosis of ITP Platelet count <100,000/µL. H. pylori-positive or H. pylori-negative based on stool antigen test

Exclusion criteria

• • Patients with other causes of thrombocytopenia (e.g., leukemia, aplastic anemia).

• Severe comorbidities (e.g., uncontrolled diabetes, severe cardiac disease).
• Recent use (within 4 weeks) of antibiotics, proton pump inhibitors, or bismuth compounds.
• Concurrent use of medications that interfere with H. pylori therapy or platelet levels.
• Pregnant or lactating women.
• Known allergy or intolerance to eradication therapy agents (clarithromycin, amoxicillin, metronidazole).
• High risk of poor compliance (e.g., psychiatric illness).