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

Prevalence of Disorders of Gut-Brain-Interaction in Pediatric Patients With In-remission Inflammatory Bowel Disease: an Italian Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: IBS (Irritable Bowel Syndrome); IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Other: DGBI prevalence

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD group; in remission IBD pediatric patients	Other: DGBI prevalence; All the included children underwent the Rome IV validated questionnaire (QPGS-RIV) to diagnose DGBIs
Control group; healthy subjects were followed for periodic health and auxologic assessment	Other: DGBI prevalence; All the included children underwent the Rome IV validated questionnaire (QPGS-RIV) to diagnose DGBIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Valentina Giorgio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colonic Diseases, Functional; Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Other Study ID Numbers: ID 7277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No