Assessment of Hematological Effect of H.Pylori and H.Pylori Eradication Therapy Among a Sample of Iraqi ITP Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Platelet Count After H. pylori Eradication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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).
研究组 & 干预措施
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.
干预措施: Levofloxacin-Based H. pylori Eradication Therapy (Drug)
结局指标
主要结局
Change in Platelet Count After H. pylori Eradication
时间窗: 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).
次要结局
未报告次要终点
研究者
Murtadha Al-Owayef
Murtadha Salah Shyaa Al-OWAYEF
Al-Mustansiriyah University