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Stomach acid drugs may skew h. pylori stool test results

NCT ID NCT07516262

Knowledge-focused Sponsor: Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study looks at whether taking common acid-reducing drugs (proton pump inhibitors, or PPIs) affects the accuracy of a stool DNA test for H. pylori, a stomach bacteria. Researchers will test 25 adults who need PPIs, first while on the drug and then after stopping it for 4 weeks. The goal is to see if the test works better without the drug, which could help doctors diagnose H. pylori more reliably.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proton Pump Inhibitor (PPI) discontinuation
What this could lead to
If successful, this study could show that stopping PPIs for 4 weeks improves the accuracy of stool DNA tests for H. pylori, leading to better diagnosis without needing a scope.
What could go wrong
This is a very small study (25 people) and only looks at diagnostic accuracy, not treatment. Results may not apply to everyone, and the washout period may be inconvenient or risky for some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

49 people

The number who actually took part.

Started

Jun 2025

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged 18-80 years requiring PPI therapy for gastritis or peptic ulcer disease, with no prior H. pylori eradication therapy, and confirmed H. pylori infection (≥2 positive among antibody, histology, and RUT). Exclusion criteria include pregnancy, lactation, acute gastrointestinal bleeding, subtotal gastrectomy, severe organ dysfunction, recent antibiotic use (within 4 weeks), substance abuse, and conditions affecting compliance or safety. All participants provide written informed consent.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients aged 18-80 years; * No prior H. pylori eradication therapy; * Patients requiring proton pump inhibitor (PPI) therapy in the near future due to gastritis, peptic ulcer disease, or other indicated conditions; * Patients with at least two positive results among H. pylori antibody test, histology, and rapid urease test (RUT); * Provision of signed informed consent and being informed of the specific study protocol. Exclusion Criteria: * Prior H. pylori eradication therapy; * Pregnant or lactating women; * Acute gastrointestinal bleeding; * History of subtotal gastrectomy; * Severe dysfunction of vital organs (heart, liver, kidney, lungs, etc.) or congenital diseases, such as class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.; * Refusal of enrollment by the guardian or the patient; * Alcohol and/or drug abuse (addiction or dependence), or poor compliance as judged by the investigator; * Individuals without legal capacity or with impaired insight; * Abnormal neurological signs on physical examination; * Use of oral antibiotics with bactericidal activity against H. pylori within 4 weeks.

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Conditions

The condition(s) this trial relates to.

Helicobacter pylori infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Helicobacter pylori infection

Contacts and locations

Locations

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127, China

More trials for these conditions

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