Effect of Helicobacter Pylori Eradication on Gastrointestinal Symptoms in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in gastrointestinal symptoms after Helicobacter pylori eradication.
研究概览
简要总结
This study aims to evaluate the effect of Helicobacter pylori eradication on gastrointestinal symptoms in adult patients. H. pylori infection is a common cause of dyspepsia and other upper gastrointestinal complaints. The trial will assess whether successful eradication therapy leads to significant improvement in symptoms compared to baseline. Adult patients diagnosed with H. pylori infection will receive standard eradication treatment, and symptom changes will be monitored using validated questionnaires over a defined follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older.
- •Confirmed diagnosis of Helicobacter pylori infection by one or more diagnostic tests.
- •Presence of any upper or lower gastrointestinal symptoms.
- •Willingness to undergo H. Pylori eradication therapy and follow-up.
- •Ability to provide informed consent.
排除标准
- •Age less than 18 years.
- •The previously unsuccessful application of empirical H. pylori eradication therapy.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs).
- •Any malignant disease of the stomach or any other site.
- •Any associated comorbidity (renal insufficiency, mental illness).
- •History of allergies to proton pump inhibitors or antibiotics.
- •Refusal to participate in the survey.
结局指标
主要结局
Change in gastrointestinal symptoms after Helicobacter pylori eradication.
时间窗: 6 weeks
Gastrointestinal symptom improvement will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 items, each scored from 1 to 7, giving a total score range of: Minimum score: 1 (absence of symptoms) Maximum score: 7 (most severe symptoms) Higher scores indicate worse gastrointestinal symptoms. Change will be calculated by comparing baseline scores to follow-up scores after completion of eradication therapy.
Eradication success rate.
时间窗: 8 weeks
Proportion of patients achieving confirmed eradication of Helicobacter pylori using non-invasive testing (either urea breath test or stool antigen test), performed after completing eradication therapy.
次要结局
未报告次要终点
研究者
Amany Usama Ahmed Arafa
Resident doctor, Tropical Medicine and Gastroenterology
Sohag University