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

NCT07272681 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25-11-1MS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Dyspepsia; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Study Arms (1)

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

Adult patients with confirmed Helicobacter pylori infection who have received standard eradication therapy prescribed by their healthcare providers. The study will observe and evaluate changes in gastrointestinal symptoms after completion of the prescribed treatment, without altering or influencing the treatment regimen.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amany Usama Ahmed Arafa: lead

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amany Usama

  Department of Gastroenterology and Tropical medicine Sohag University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany Usama

CONTACT

+201113063055; Amany_osama_post@med.sohag.edu.eg

Arafa

CONTACT

Amany_osama_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor, Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12