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Blood test may spot hidden gut trouble in kids with rare disease

NCT ID NCT07664228

Diagnosis Sponsor: Bursa City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a protein in the blood, called I-FABP, can tell doctors if a child's IgA vasculitis is affecting their stomach or intestines. Researchers will take blood samples from 100 children at diagnosis and again 2-4 weeks later. If I-FABP levels are linked to gut symptoms, it could become a simple tool to guide treatment decisions.

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 simple blood test that helps doctors quickly identify which children with IgA vasculitis have gut involvement, allowing for earlier treatment.
What could go wrong
This is a small, early observational study, not a treatment trial. The blood marker may not prove accurate enough for routine use, and results may not apply to all children.

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 100 people

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

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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 2-18 years with newly diagnosed IgA vasculitis who are followed at a tertiary pediatric rheumatology center. Participants will be prospectively evaluated for gastrointestinal involvement and plasma I-FABP levels at diagnosis and during routine follow-up approximately 2-4 weeks later.

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: * Diagnosis of IgA vasculitis (Henoch-Schönlein purpura) according to EULAR/PRINTO/PRES classification criteria. * Age between 2 and 18 years. * Availability for blood sample collection at diagnosis (baseline visit). * Ability to attend a routine follow-up visit approximately 2-4 weeks after diagnosis. * Parent or legal guardian able and willing to provide written informed consent. Exclusion Criteria: * Refusal of informed consent by the parent/legal guardian. * Inability to obtain a baseline blood sample. * Inability to complete study follow-up procedures.

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Conditions

The condition(s) this trial relates to.

immunoglobulin A vasculitis

As listed by the trial registrant

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

Gastrointestinal involvement IgA vasculitis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Bursa City Hospital

    RECRUITING

    Bursa, Bursa, 16250, Turkey (Türkiye)

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