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Could a stomach infection worsen lupus? new study investigates

NCT ID NCT07157202

Knowledge-focused Sponsor: Assiut University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This observational study will check if having an H. pylori stomach infection is linked to more active lupus in 115 adults. Researchers will use a stool test to detect the bacteria and a standard lupus score to measure disease activity. No treatments are given; the goal is simply to see if a connection exists.

What this could mean

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

What this could lead to
If a link is found, it could point toward managing lupus by treating H. pylori infections.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may not lead to any treatment changes.

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

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

Eligible participants are adults (at least 18 years old) diagnosed with SLE according to ACR or SLICC criteria, who have not used antibiotics or proton pump inhibitors in the past four weeks, and provide written informed consent . Patients with prior gastric surgery, GI cancer, immunosuppressive therapy for non-SLE conditions, coexisting autoimmune diseases, pregnancy or lactation, or any current active infection other than H. pylori at enrollment are excluded . Of those eligible, the expected sample size is 115 patients, calculated to power the main outcome analysis. Demographic details (age, sex, ethnicity, disease duration, smoking status, and family history) and clinical manifestations (SLE-related symptoms, medications, and organ involvement) will be thoroughly documented to ensure a well-characterized, representative population .

Ages

18 years and older

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: * Adult patients (aged ≥18 years) with a confirmed diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Patients who provide written informed consent to participate in the study. Patients who have not received antibiotics or proton pump inhibitors (PPIs) in the four weeks Exclusion Criteria: * Patients with a history of gastric surgery or known gastrointestinal malignancy. * Patients currently receiving immunosuppressive therapy for conditions other than SLE. * Patients with coexisting autoimmune diseases other than SLE. * Pregnant or lactating women. * Patients with active infections (other than H. pylori) at the time of enrollment.

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Conditions

The condition(s) this trial relates to.

Helicobacter pylori infectious disease systemic lupus erythematosus

As listed by the trial registrant

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

H pylori SLE - systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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