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

NCT07150286 | Completed

• 1 other identifier: 96
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenic Purpura; HELICOBACTER PYLORI INFECTIONS

Keywords

immune thrombocytopenia; ITP; Helicobacter pylori; H.pylori; Levofloxacin-based Triple Therapy; Salvage Therapy; Hematology; Iraq

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Count After H. pylori Eradication

  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).

  Baseline and 4 weeks post-therapy

Study Arms (2)

H. pylori-Positive ITP Patients - Eradication Therapy

EXPERIMENTAL

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.

Drug: Levofloxacin-Based H. pylori Eradication Therapy

H. pylori-Negative ITP Patients - No Therapy

NO INTERVENTION

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.

Interventions

Levofloxacin-Based H. pylori Eradication Therapy 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-Positive ITP Patients - Eradication Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

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

Baghdad, Baghdad Governorate, 10001, Iraq

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

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

Study Officials

• Manal Khalid Abdulridha, proffessor at Mustansiriyah

  Al-Mustansiriyah University - National Center of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Murtadha Salah Shyaa Al-OWAYEF

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 1, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

IR (1)