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

Effect of Helicobacter Pylori Eradication on Gastrointestinal Symptoms in Adult Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07272681

Acronym

HPE-GI

Enrollment

100

Registered

2025-12-09

Start date

2025-12-20

Completion date

2026-12-20

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Gastrointestinal Symptoms, Helicobacter Pylori Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in gastrointestinal symptoms after Helicobacter pylori eradication.	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.	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.

Contacts

Primary ContactAmany Usama

Amany_osama_post@med.sohag.edu.eg+201113063055

Backup ContactArafa

Amany_osama_post@med.sohag.edu.eg

Outcome results