Skip to main content
OpenTrials
Completed

NCT Number: NCT07610694

Eating Disorders in Patients With IBD

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic relapsing conditions characterized by persistent inflammatory activity, unpredictable disease course, and recurrent gastrointestinal symptoms. These factors may substantially influence patients' dietary habits. Many patients with IBD modify or restrict their diet in an attempt to prevent symptom exacerbation or disease flares. Although dietary restriction may represent an adaptive behaviour during active disease, it may persist over time and become maladaptive.

Restrictive eating behaviours in IBD may overlap with eating disorders, including avoidant/restrictive food intake disorder (ARFID). ARFID is characterized by restrictive food intake that is not primarily driven by body image concerns, but rather by mechanisms such as fear of adverse gastrointestinal consequences, low appetite or reduced interest in eating, and avoidance of specific foods. In patients with IBD, these behaviours may contribute to nutritional impairment, psychological distress, and disability.

This observational cross-sectional study assesses the prevalence of eating disorder risk and ARFID risk among adult patients with a confirmed diagnosis of IBD. Consecutive eligible patients are enrolled during routine outpatient visits. Demographic and clinical data are collected at enrolment, including disease type, age at diagnosis, disease duration, disease phenotype, previous treatments, previous surgery, extraintestinal manifestations, current therapy, laboratory markers, and disease activity.

Eating disorder risk is assessed using the Eating Attitudes Test-26 (EAT-26). ARFID risk is evaluated using the Nine-Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS-9), including its subdomains related to picky eating, low appetite or limited interest in eating, and fear of adverse consequences. Nutritional status is assessed using the Patient-Generated Subjective Global Assessment (PG-SGA). IBD-related disability is evaluated using the IBD-Disk and a modified IBD-Disk including a diet-related item.

Clinical disease activity is assessed using validated disease-specific indices, including the partial Mayo score for ulcerative colitis and the Harvey-Bradshaw Index for Crohn's disease. Endoscopic activity, when available, is evaluated using the Mayo Endoscopic Subscore for ulcerative colitis and the Simple Endoscopic Score for Crohn's Disease for Crohn's disease. The study also evaluates associations between altered eating behaviours, disease activity, malnutrition risk, dietary impairment, and IBD-related disability.

The study aims to improve the identification of patients with IBD who are at risk of maladaptive restrictive eating behaviours and who may benefit from structured nutritional or psychological assessment as part of routine IBD care. The uploaded study describes the same core design elements: adult IBD patients enrolled during routine outpatient visits, ARFID risk assessed with NIAS-9, eating disorder risk with EAT-26, nutritional status with PG-SGA, and disability with IBD-Disk/mDISK. 

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Single time point at enrolment

    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.

Secondary outcomes

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

    Time frame: Single time point at enrolment

    The proportion of adult patients with inflammatory bowel disease who screen positive for eating disorder risk. Eating disorder risk is assessed using the validated Eating Attitudes Test-26 (EAT-26). A total EAT-26 score of 20 or higher identifies participants at risk for eating disorders and indicates the need for further clinical evaluation.

  2. Association between ARFID risk and malnutrition risk

    Time frame: Single time point at enrolment

    The association between avoidant/restrictive food intake disorder risk and malnutrition risk among adult patients with inflammatory bowel disease. ARFID risk is assessed using the Nine-Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS-9), while nutritional status is evaluated using the Patient-Generated Subjective Global Assessment (PG-SGA). A PG-SGA (ranging 0-36) score of 6 or higher identifies participants at high risk of malnutrition.

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

    Time frame: Single time point at enrolment

    This outcome assesses the association between avoidant/restrictive food intake disorder risk and inflammatory bowel disease-related disability. ARFID risk is assessed using the Nine-Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS-9). IBD-related disability is assessed using the IBD-Disk (score ranging 0-100), a patient-reported instrument evaluating the impact of IBD on symptoms, daily functioning, and psychosocial well-being. Moderate-to-severe disability is defined as an IBD-Disk score of 40 or higher.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Università Vita-Salute San Raffaele

Registry information

Official study title

Prevalence of Eating Disorders in Patients With Inflammatory Bowel Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.