Prevalence of Disorders of Gut-Brain-Interaction in Pediatric Patients With In-remission Inflammatory Bowel Disease

NCT07539077 | Completed DMC

• 1 other identifier: ID 7277
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The medical management of inflammatory bowel disease (IBD) has evolved over the years thanks to the newly available therapies and the biochemical and endoscopic monitoring of the disease. Several in-remission IBD patients still complain of gastrointestinal symptoms, suggesting a possible overlap between IBD and Disorders of Gut-Brain-Interaction (DGBIs), classified and diagnosed according to the Rome IV criteria, with a worldwide prevalence of about 40% in the general population. In adult patients with in-remission IBD, the prevalence of any DGBI has been reported to reach up to 41%, resulting in significantly higher rates in Crohn's disease (CD) than in ulcerative colitis (UC). Regarding the pediatric population, according to a meta-analysis conducted in 2015, the worldwide prevalence of functional abdominal pain disorders (FAPDs), a subtype of DGBIs including functional dyspepsia, irritable bowel syndrome (IBS), abdominal migraine, and functional abdominal pain not otherwise specified (FAP-NOS), in children is about 13.5%, with IBS reported as the most frequent disorder (8.8%). Only a few studies were conducted on pediatric patients to investigate the association between IBD and DGBIs. A meta-analysis conducted in 2022 reported an overall prevalence of FAPDs ranging between 9.6% and 29.5% in children with in-remission IBD, with the overall prevalence of IBS in these patients ranging between 3.9% and 16.1%. Therefore, despite the differences in criteria used to define quiescent IBD in the included studies, an increased overall prevalence of IBS and FAPDs in children with IBD was described. Nevertheless, none used the current Rome IV criteria to diagnose DGBIs, and only the prevalence of IBS and FAPDs was analyzed. The primary aim of our study was to assess the prevalence of commonly reported DGBIs (Functional nausea and vomiting disorders, Functional abdominal pain disorders, Functional defecation disorders) in pediatric patients with quiescent IBD, compared to a control group of healthy children. Secondly, we aimed to investigate the presence of any other factors associated with the presence of DGBIs in our population, regardless of the IBD status.

Conditions

IBD (Inflammatory Bowel Disease); IBS (Irritable Bowel Syndrome)

Outcome Measures

Primary Outcomes (1)

• Commonly reported DGBIs in pediatric patients

  Prevalence of commonly reported DGBIs in pediatric patients with quiescent IBD, compared to a control group of healthy children.

  Baseline

Study Arms (2)

IBD group

in remission IBD pediatric patients

Other: DGBI prevalence

Control group

healthy subjects were followed for periodic health and auxologic assessment

Other: DGBI prevalence

Interventions

DGBI prevalence OTHER

All the included children underwent the Rome IV validated questionnaire (QPGS-RIV) to diagnose DGBIs

Control group; IBD group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• diabetes (type I and II)
• thyroid disease
• major abdominal surgery in the previous two years
• connective tissue disease
• ongoing corticosteroid or antibiotic therapy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Study Officials

• Valentina Giorgio

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 20, 2026
• Study Start: March 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

IT (1)