- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610694
Eating Disorders in Patients With IBD
Prevalence of Eating Disorders in Patients With Inflammatory Bowel Disease
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.
Study Overview
Status
Detailed Description
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. 
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Naples, Italy, 80131
- University of Naples Federico II
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of avoidant/restrictive food intake disorder risk among adult patients with inflammatory bowel disease
Time Frame: Single time point at enrolment
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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.
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Single time point at enrolment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of eating disorder risk among adult patients with inflammatory bowel disease
Time Frame: Single time point at enrolment
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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.
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Single time point at enrolment
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Association between ARFID risk and malnutrition risk
Time Frame: Single time point at enrolment
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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.
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Single time point at enrolment
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Association between avoidant/restrictive food intake disorder risk and IBD-related disability
Time Frame: Single time point at enrolment
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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.
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Single time point at enrolment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nutrition Disorders
- Signs and Symptoms, Digestive
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Gastroenteritis
- Colitis
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Avoidant Restrictive Food Intake Disorder
- Malnutrition
- Colitis, Ulcerative
- Crohn Disease
- Inflammatory Bowel Diseases
- Feeding and Eating Disorders
Other Study ID Numbers
- 117/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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