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NCT Number: NCT07272681

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

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.

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Key information

Conditions

Helicobacter Pylori Infection Dyspepsia Gastrointestinal Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Change in gastrointestinal symptoms after Helicobacter pylori eradication.

    Time frame: 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.

  2. Eradication success rate.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany Usama

CONTACT

[email protected]

+201113063055

Arafa

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Amany Usama Ahmed Arafa

Other

Registry information

Official study title

Effect of Helicobacter Pylori Eradication on Gastrointestinal Symptoms in Adult Patients

Acronym: HPE-GI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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