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A simple stool test might replace scopes for kids with gut issues

NCT ID NCT07807527

Diagnosis Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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)

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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

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Status unknown
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First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers at Assiut University are testing whether a stool test for calprotectin, a protein linked to inflammation, can accurately detect gut inflammation in children with chronic digestive symptoms. The study will compare stool test results with findings from endoscopy and tissue biopsies, which are the current standard. If the test works well, it could offer a less invasive way to diagnose conditions like inflammatory bowel disease in children.

What this could mean

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

Active substance
Fecal calprotectin test (stool test measuring calprotectin levels)
What this could lead to
If the stool test proves reliable, it could reduce the need for invasive endoscopies in children with gut symptoms.
What could go wrong
This is a small, early study, and the test may not match the accuracy of endoscopy. Also, certain medications or other conditions could affect results.

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 120 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

Children aged 2 to 18 years presenting with chronic or recurrent gastrointestinal symptoms and scheduled for endoscopic evaluation at the Pediatric Gastroenterology and Endoscopy Units, Assiut University Children Hospital.

Ages

2 to 18 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: * \- Age 2 to 18 years * Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive) * Scheduled for upper gastrointestinal endoscopy and/or ileocolonoscopy with mucosal biopsy * Written informed consent from parents or legal guardians Exclusion Criteria: * Age below 2 years * Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling * Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation * Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis * Refusal of parents or legal guardians to participate * Failure to obtain an adequate stool sample

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Conditions

The condition(s) this trial relates to.

digestive system disorder inflammatory bowel disease

As listed by the trial registrant

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

Gastrointestinal diseases Inflammatory bowel diseases

How to take part

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  1. The official record

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