HELICOBACTER PYLORI INFECTIONS, Immune Thrombocytopenic Purpura
Conditions
Keywords
immune thrombocytopenia, ITP, Helicobacter pylori, H.pylori, Levofloxacin-based Triple Therapy, Salvage Therapy, Hematology, Iraq
Brief 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.
Interventions
DRUGLevofloxacin-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.
Sponsors
Al-Mustansiriyah University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. All participants, investigators, and care providers are aware of group assignments, as treatment allocation is based on H. pylori infection status.
Intervention model description
This is a two-arm, parallel-group study. Patients with ITP who test positive for H. pylori receive a 14-day levofloxacin-based eradication regimen, while H. pylori-negative ITP patients serve as the comparison group without eradication therapy. Platelet counts are monitored before and after treatment to assess hematological response.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Platelet Count After H. pylori Eradication | Baseline and 4 weeks post-therapy | The primary outcome is the absolute change in platelet count (×10⁹/L) from baseline to four weeks after completion of levofloxacin-based H. pylori eradication therapy in H. pylori-positive ITP patients. Platelet counts will be measured using standard hematology analyzers (Hemmary 86 and Cellagon 5 Pro). |
Countries
Iraq
Outcome results
None listed