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

ConditionsHelicobacter Pylori Infection Dyspepsia Gastrointestinal Symptoms

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAmany Usama Ahmed Arafa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients (≥18 years) diagnosed with Helicobacter pylori infection by invasive or non-invasive tests (urea breath test or stool antigen test) and who have completed standard eradication therapy prescribed by their healthcare providers. The population includes both male and female patients presenting with gastrointestinal symptoms such as dyspepsia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants

are grouped into 1 trial group

Group A: H. pylori-positive adults - Eradication therapy group - Adult patients with H. pylori infection

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amany Usama Ahmed Arafa

Lead sponsor

Sohag University

Sponsor institution

Source ClinicalTrials.gov

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