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Hidden Gut-Brain issues common in kids with IBD, study finds

NCT ID NCT07539077

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Italian study looked at how often children with inactive inflammatory bowel disease (IBD) also have disorders of gut-brain interaction (DGBIs), like irritable bowel syndrome. Researchers used the Rome IV questionnaire to compare 220 children with quiescent IBD to healthy children. The goal is to better understand and manage these overlapping symptoms.

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 this study succeeds, it could help doctors better recognize and manage overlapping gut-brain symptoms in children with IBD, improving their quality of life.
What could go wrong
This is an observational study that only measures prevalence, not a treatment trial. Results may not apply to all children or lead to direct changes in care.

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

220 people

The number who actually took part.

Started

Mar 2025

Finished

Dec 2025

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

Pediatric patients with quiescent IBD recruited during their routine control visit at the Outpatients Pediatric Gastrointestinal Unit of three Italian referral centres in Rome, Italy (Fondazione Policlinico Universitario A. Gemelli IRCCS, Sapienza University of Rome - Sant'Andrea University Hospital, Bambino Gesù Children Hospital).

Ages

4 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: In-remission IBD patients: * Clinical remission was defined as PUCAI/aPCDAI \< 10 * biochemical remission was defined as CRP \< 0.5 mg/ml and faecal calprotectin \< 100 microg/g * Endoscopic remission defined as CDEIS \< 6 for CD and Mayo score ≤ 1 for UC. Exclusion Criteria: * diabetes (type I and II) * thyroid disease * major abdominal surgery in the previous two years * connective tissue disease * ongoing corticosteroid or antibiotic therapy.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease irritable bowel syndrome ulcerative colitis

As listed by the trial registrant

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

IBD (inflammatory bowel disease) IBS - irritable bowel syndrome

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168, Italy

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