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Not yet recruitingNCT07272681HPE-GIUpdated Dec 16, 2025

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

An observational study in Helicobacter Pylori Infection, Dyspepsia and Gastrointestinal Symptoms, sponsored by Amany Usama Ahmed Arafa. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Amany Usama Ahmed Arafa · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Helicobacter Pylori Infection
  • Dyspepsia
  • Gastrointestinal Symptoms

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03

In context

Dyspepsia

372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 62 observational studies indexed under Dyspepsia.

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Lead sponsor

This is the only study on the registry with Amany Usama Ahmed Arafa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07272681
Lead sponsor
Amany Usama Ahmed Arafa
Responsible party
Amany Usama Ahmed Arafa (Resident doctor, Tropical Medicine and Gastroenterology, Sohag University) — Sponsor-investigator
First posted
Dec 9, 2025
Start date
Dec 20, 2025 (estimated)
Primary completion
Jun 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Dec 16, 2025

Study contacts

Amany Usama
Contact
Amany_osama_post@med.sohag.edu.eg
+201113063055
Amany Usama
principal investigator · Department of Gastroenterology and Tropical medicine Sohag University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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