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Painless ultrasound may spot celiac Flare-Ups without a needle

NCT ID NCT07453589

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study explores whether a simple ultrasound and a blood test can track celiac disease activity, potentially replacing the need for invasive intestinal biopsies. Researchers will scan the small bowel and measure antibody levels in 140 people, including newly diagnosed patients and those already on a gluten-free diet. If the ultrasound score matches the blood test results, it could offer a gentler way to monitor the disease over time.

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 successful, this could lead to a non-invasive way to monitor celiac disease activity and response to a gluten-free diet, reducing the need for repeated biopsies.
What could go wrong
This is an early observational study, not a treatment trial. The ultrasound scoring system is new and may not prove accurate enough to replace biopsies in all cases.

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 140 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 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

The study population consists of individuals aged 2 years and older recruited from the Department of Gastroenterology and Hepatology at AL-Rajhi University Hospital, Egypt. This includes patients with suspected or newly diagnosed celiac disease, previously diagnosed patients being monitored on a gluten-free diet, individuals undergoing screening due to a family history of celiac disease, and a control group of individuals with negative serology.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients aged ≥2 years with suspected celiac disease based on clinical symptoms (chronic diarrhea, abdominal distention, weight loss, failure to thrive). * Newly diagnosed celiac disease patients with positive tTG antibodies and/or duodenal biopsy confirmation. * Previously diagnosed celiac disease patients on gluten-free diet requiring follow-up assessment. * Patients with first-degree relatives with celiac disease undergoing screening. * Patients who provide informed consent (or parental consent for minors). Exclusion Criteria: * Previous small bowel surgery or resection. * Inflammatory bowel disease (Crohn's disease, ulcerative colitis). * Small bowel obstruction from other causes. * IgA deficiency (requires alternative antibody testing). * Patients on immunosuppressive therapy. * Pregnancy. * Poor quality ultrasound images due to excessive bowel gas or obesity. * Refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

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

Celiac disease Small bowel ultrasonography Tissue transglutaminase antibody Ultrasound

How to take part

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  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

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Other studies related to the condition(s) this trial covers.