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

NCT ID: NCT07150286

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-04-01

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.

Conditions

Immune Thrombocytopenic Purpura; HELICOBACTER PYLORI INFECTIONS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H. pylori-Positive ITP Patients - Eradication Therapy

Patients who test positive for Helicobacter pylori will receive a 14-day levofloxacin-based triple therapy regimen according to ACG guidelines. Platelet counts will be measured at baseline and four weeks after completion of therapy to assess hematological response.

Group Type: EXPERIMENTAL

Levofloxacin-Based H. pylori Eradication Therapy

Intervention Type: DRUG

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.

H. pylori-Negative ITP Patients - No Therapy

Patients who test negative for H. pylori will not receive eradication therapy. Platelet counts will be monitored at the same time points as the intervention group to serve as a comparison for evaluating treatment effects.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Mustansiriyah University

OTHER

Sponsor Role: lead

Responsible Party

Murtadha Al-Owayef

Murtadha Salah Shyaa Al-OWAYEF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal Khalid Abdulridha, proffessor at Mustansiriyah

Role: PRINCIPAL_INVESTIGATOR

Al-Mustansiriyah University - National Center of Hematology

Locations

Al-Mustansiriyah University - college of pharmacy - clinical pharmacy department

Baghdad, Baghdad Governorate, Iraq

Countries

Iraq

Other Identifiers

96

Identifier Type: -

Identifier Source: org_study_id