Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT07610694
Eating Disorders in Patients With IBD
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Crohn Disease (CD), run by Federico II University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD), Ulcerative Colitis (UC)
- How many people
- 355 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Previous diagnosis or known history of eating disorders.
- Severe unmanaged psychiatric conditions.
- Pregnancy.
- Inability to complete the questionnaires or provide reliable study information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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. 
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD), Ulcerative Colitis (UC), ARFID, Eating Disorders
- Keywords
- ARFID, Food avoidance, Eating disorders, Disability, Malnutrition, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Avoidant Restrictive Food Intake Disorder, Feeding and Eating Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single time point at enrolment
Secondary outcomes (3)
Prevalence of eating disorder risk among adult patients with inflammatory bowel disease
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.
Measured: Single time point at enrolment
Association between ARFID risk and malnutrition risk
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.
Measured: Single time point at enrolment
Association between avoidant/restrictive food intake disorder risk and IBD-related disability
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.
Measured: Single time point at enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start10 Oct 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Fabiana Castiglione, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610694
- Sponsor's protocol ID
- 117/2025
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Eating Disorders in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07610694
- Acronym / sponsor ID
- 117/2025
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD), Ulcerative Colitis (UC), ARFID, Eating Disorders
- Keywords
- ARFID, Food avoidance, Eating disorders, Disability, Malnutrition, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous diagnosis or known history of eating disorders.
- Severe unmanaged psychiatric conditions.
- Pregnancy.
- Inability to complete the questionnaires or provide reliable study information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Prevalence of eating disorder risk among adult patients with inflammatory bowel disease
Time frame: Single time point at enrolment
Association between ARFID risk and malnutrition risk
Time frame: Single time point at enrolment
Association between avoidant/restrictive food intake disorder risk and IBD-related disability
Time frame: Single time point at enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Crohn Disease (CD), run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of avoidant/restrictive food intake disorder risk among adult patients with inflammatory bowel disease (time frame: Single time point at enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.