Effect of H. Pylori Eradication on The Improvement of Gastrointestinal Symptoms

N/ANot Yet RecruitingNCT07272681

Amany Usama Ahmed Arafa100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Helicobacter Pylori Infection Dyspepsia Gastrointestinal Symptoms

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 18 years and older. 2. Confirmed diagnosis of Helicobacter pylori infection by one or more diagnostic tests. 3. Presence of any upper or lower gastrointestinal symptoms. 4. Willingness to undergo H. Pylori eradication therapy and follow-up. 5. Ability to provide informed consent. Exclusion Criteria: 1. Age less than 18 years. 2. The previously unsuccessful application of empirical H. pylori eradication therapy. 3. Use of non-steroidal anti-inflammatory drugs (NSAIDs). 4. Any malignant disease of the stomach or any other site. 5. Any associated comorbidity (renal insufficiency, mental illness). 6. History of allergies to proton pump inhibitors or antibiotics. 7. Refusal to participate in the survey.

Outcomes

Primary Outcomes

Change in gastrointestinal symptoms after Helicobacter pylori eradication.

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.

Time frame: 6 weeks

Eradication success rate.

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.

Time frame: 8 weeks