NCT07610694

Brief Summary

Inflammatory bowel diseases (IBD) may influence eating habits and lead some patients to adopt restrictive dietary behaviours to control gastrointestinal symptoms. In some cases, these behaviours may become maladaptive and resemble eating disorders, including avoidant/restrictive food intake disorder (ARFID). This observational cross-sectional study assesses the prevalence of eating disorder risk and ARFID risk among adult patients with IBD. Participants complete validated questionnaires evaluating eating behaviours, nutritional status, and IBD-related disability. Clinical and demographic data are also collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 19, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

ARFIDFood avoidanceEating disordersDisabilityMalnutritionInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of avoidant/restrictive food intake disorder risk among adult patients with inflammatory bowel disease

    The primary outcome is the proportion of adult patients with inflammatory bowel disease who screen positive for avoidant/restrictive food intake disorder risk. ARFID risk is assessed using the validated Nine-Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS-9), which evaluates restrictive eating behaviours across three domains: picky eating, low appetite or limited interest in eating, and fear of adverse consequences. A NIAS-9 total score of 24 or higher identifies participants at risk for ARFID.

    Single time point at enrolment

Secondary Outcomes (3)

  • Prevalence of eating disorder risk among adult patients with inflammatory bowel disease

    Single time point at enrolment

  • Association between ARFID risk and malnutrition risk

    Single time point at enrolment

  • Association between avoidant/restrictive food intake disorder risk and IBD-related disability

    Single time point at enrolment

Study Arms (1)

Adult patients diagnosed with Inflammatory Bowel Disease

Adult patients with a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, enrolled during routine outpatient visits.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, enrolled during routine outpatient visits at participating IBD centres. Participants complete validated questionnaires assessing eating behaviours, nutritional status, and IBD-related disability, with concurrent collection of clinical and demographic data.

You may qualify if:

  • Adult patients aged 18 years or older.
  • Confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis.
  • Patients evaluated during routine outpatient IBD visits.
  • Ability to understand and complete the study questionnaires.

You may not qualify if:

  • Previous diagnosis or known history of eating disorders.
  • Severe unmanaged psychiatric conditions.
  • Pregnancy.
  • Inability to complete the questionnaires or provide reliable study information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn DiseaseAvoidant Restrictive Food Intake DisorderFeeding and Eating DisordersMalnutrition

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 28, 2026

Study Start

October 10, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the dataset includes sensitive clinical and questionnaire-based information. Aggregate results will be shared through publications and scientific presentations.

Locations