Celiac Disease in ChildrenNCT07285512
Eating Behaviors in Children and Adolescents With/Without Celiac Disease
An observational study of Celiac Disease in Children and Eating Behaviors, run by IRCCS San Raffaele.
Trial summary
This observational study investigates the prevalence and severity of disordered eating behaviors in adolescents aged 11-17 years with celiac disease. Participants complete validated self-report questionnaires (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Eating Behaviors
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will enroll adolescents aged 11-17 years, including two groups: (1) patients with a confirmed diagnosis of celiac disease, and (2) healthy controls matched by age and sex. Participants in the celiac disease group are recruited from the Pediatric Unit of IRCCS Ospedale San Raffaele and must have a diagnosis established according to ESPGHAN guidelines; a subset diagnosed within the previous 6 months will be included in a longitudinal follow-up. Healthy controls are recruited from outpatient pediatric clinics and local schools and must have no chronic medical conditions requiring dietary therapy. All participants must be able to understand Italian and complete self-report questionnaires, with a caregiver available to complete the parent-report instrument.
Who may be able to join
- Celiac Disease Group (Cases)
- Adolescents aged 11 to 17 years
- Confirmed diagnosis of celiac disease according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy)
- Ability to understand and complete questionnaires in Italian
- For the longitudinal cohort: diagnosis < 6 months prior to enrollment
- Healthy Control Group
Show all 9Show fewer
- Adolescents aged 11 to 17 years
- No diagnosis of celiac disease
- Ability to understand and complete questionnaires in Italian
Who cannot join
- Significant cognitive impairment or developmental disorders preventing questionnaire completion
- Inadequate understanding of the Italian language
- Refusal or inability to provide assent/consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
This observational study investigates the prevalence and severity of disordered eating behaviors in adolescents aged 11-17 years with celiac disease. Participants complete validated self-report questionnaires (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q) and a structured clinical form. A healthy control group, matched by age and sex, is included for comparison. A longitudinal sub-cohort diagnosed with celiac disease <6 months prior will be followed at 6, 12, and 24 months to evaluate changes in eating psychopathology and associated clinical variables.
Read the detailed description
Celiac disease (CD) is a chronic autoimmune condition that requires lifelong adherence to a strict gluten-free diet. Adolescence represents a period of heightened vulnerability for the development of disordered eating behaviors, particularly in chronic conditions requiring dietary restrictions. Emerging evidence suggests that youths with CD may be at increased risk of problematic eating behaviors, including shape and weight concerns, dietary restraint, and loss-of-control eating; however, data in pediatric CD populations are limited and inconsistent.
This study aims to characterize eating-related psychopathology in adolescents aged 11-17 years with a diagnosis of CD, using validated instruments adapted for youth (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q). The study has both a cross-sectional and a longitudinal component.
The cross-sectional component will compare adolescents with CD to age- and sex-matched healthy controls recruited from outpatient pediatric services and local schools. Participants will complete an online self-report questionnaire battery including the YEDE-Q and a structured clinical and psychosocial survey assessing diagnostic history, gastrointestinal symptoms, lifestyle factors, adherence to the gluten-free diet, academic functioning, and co-morbidities. Parents or caregivers will complete the PEDE-Q. The primary outcome is the global score of the YEDE-Q.
The longitudinal component includes a sub-cohort of adolescents diagnosed with CD within the past six months. These participants will be reassessed at 6, 12, and 24 months post-diagnosis to evaluate trajectories of eating psychopathology and identify factors associated with the emergence, persistence, or remission of disordered eating behaviors over time.
No biological samples are collected, and no experimental interventions are administered. All data are obtained through questionnaires. The study is conducted at IRCCS Ospedale San Raffaele, Milan, Italy.
The overarching goal is to improve early recognition of disordered eating in adolescents with CD, inform clinical practice, and contribute foundational data for future preventive interventions in this population.
- Conditions
- Celiac Disease in Children, Eating Behaviors
- Medical subject headings
- Feeding Behavior
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 |
|---|---|---|
| Celiac disease group | Adolescents aged 11-17 years with a confirmed diagnosis of celiac disease, established according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy). Participants may be at any time point after diagnosis for the cross-sectional component. A sub-cohort diagnosed <6 months prior to enrollment will participate in the longitudinal follow-up at 6, 12, and 24 months. No interventions are administered; participants complete self-report questionnaires (YEDE-Q) and parents complete the PEDE-Q, along with a structured clinical and psychosocial survey. | |
| Healthy control group | Adolescents aged 11-17 years without celiac disease or other chronic medical conditions requiring dietary therapy. Controls are matched to the CD group by age and sex. They are recruited from the general pediatric population of the hospital and from local schools. Participants complete the same self-report questionnaires (YEDE-Q) and structured survey; parents complete the PEDE-Q. Controls are included only in the cross-sectional comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores
Eating disorder psychopathology will be assessed using the YEDE-Q, completed by the adolescent. This tool evaluates restraint, eating concern, shape concern, and weight concern. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
Measured: Baseline (cross-sectional assessment)
Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores
Eating disorder psychopathology will be assessed using the PEDE-Q, completed by a caregiver. This tool evaluates restraint, eating concern, shape concern, and weight concern from the point of view of the caregiver. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
Measured: Baseline (cross-sectional assessment)
Secondary outcomes (3)
Associations Between Eating Psychopathology and Clinical/Psychosocial Variables
Associations between YEDE-Q and PEDE-Q global scores and relevant clinical and psychosocial variables will be evaluated. Variables include BMI z-score, diagnostic delay, time since diagnosis, gastrointestinal symptoms, physical activity, adherence to gluten-free diet, school functioning, and medical/psychological comorbidities.
Measured: baseline
Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)
Among adolescents with a recent diagnosis of celiac disease (<6 months), changes in eating disorder psychopathology over time will be assessed using the Youth Eating Disorder Examination Questionnaire (YEDE-Q). Repeated measures of adolescent-reported global scores (range 0-6) will be collected to evaluate progression, persistence, improvement, or remission of disordered eating symptoms.
Measured: 6 months, 12 months, and 24 months after diagnosis
Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores)
Among adolescents with a recent diagnosis of celiac disease (<6 months), changes in eating disorder psychopathology over time will be assessed using the Parent Eating Disorder Examination Questionnaire (PEDE-Q). Repeated measures of parent-reported global scores (range 0-6) will be collected to evaluate progression, persistence, improvement, or remission of disordered eating symptoms.
Measured: 6 months, 12 months, and 24 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Di Stefano, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285512
- Sponsor's protocol ID
- DAN-CD
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The dataset contains sensitive information from minors regarding health status and eating psychopathology, and sharing identifiable or potentially re-identifiable data is not permitted under institutional and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
- ClinicalTrials.gov ID
- NCT07285512
- Acronym / sponsor ID
- DAN-CD
- Conditions
- Celiac Disease in Children, Eating Behaviors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 16 Dec 2025 (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.
This observational study investigates the prevalence and severity of disordered eating behaviors in adolescents aged 11-17 years with celiac disease. Participants complete validated self-report questionnaires (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q) and a structured clinical form. A healthy control group, matched by age and sex, is included for comparison. A longitudinal sub-cohort diagnosed with celiac disease <6 months prior will be followed at 6, 12, and 24 months to evaluate changes in eating psychopathology and associated clinical variables.
Detailed description
Celiac disease (CD) is a chronic autoimmune condition that requires lifelong adherence to a strict gluten-free diet. Adolescence represents a period of heightened vulnerability for the development of disordered eating behaviors, particularly in chronic conditions requiring dietary restrictions. Emerging evidence suggests that youths with CD may be at increased risk of problematic eating behaviors, including shape and weight concerns, dietary restraint, and loss-of-control eating; however, data in pediatric CD populations are limited and inconsistent.
This study aims to characterize eating-related psychopathology in adolescents aged 11-17 years with a diagnosis of CD, using validated instruments adapted for youth (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q). The study has both a cross-sectional and a longitudinal component.
The cross-sectional component will compare adolescents with CD to age- and sex-matched healthy controls recruited from outpatient pediatric services and local schools. Participants will complete an online self-report questionnaire battery including the YEDE-Q and a structured clinical and psychosocial survey assessing diagnostic history, gastrointestinal symptoms, lifestyle factors, adherence to the gluten-free diet, academic functioning, and co-morbidities. Parents or caregivers will complete the PEDE-Q. The primary outcome is the global score of the YEDE-Q.
The longitudinal component includes a sub-cohort of adolescents diagnosed with CD within the past six months. These participants will be reassessed at 6, 12, and 24 months post-diagnosis to evaluate trajectories of eating psychopathology and identify factors associated with the emergence, persistence, or remission of disordered eating behaviors over time.
No biological samples are collected, and no experimental interventions are administered. All data are obtained through questionnaires. The study is conducted at IRCCS Ospedale San Raffaele, Milan, Italy.
The overarching goal is to improve early recognition of disordered eating in adolescents with CD, inform clinical practice, and contribute foundational data for future preventive interventions in this population.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac disease group | – | –Adolescents aged 11-17 years with a confirmed diagnosis of celiac disease, established according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy). Participants may be at any time point after diagnosis for the cross-sectional component. A sub-cohort diagnosed <6 months prior to enrollment will participate in the longitudinal follow-up at 6, 12, and 24 months. No interventions are administered; participants complete self-report questionnaires (YEDE-Q) and parents complete the PEDE-Q, along with a structured clinical and psychosocial survey. |
| Healthy control group | – | –Adolescents aged 11-17 years without celiac disease or other chronic medical conditions requiring dietary therapy. Controls are matched to the CD group by age and sex. They are recruited from the general pediatric population of the hospital and from local schools. Participants complete the same self-report questionnaires (YEDE-Q) and structured survey; parents complete the PEDE-Q. Controls are included only in the cross-sectional comparison. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will enroll adolescents aged 11-17 years, including two groups: (1) patients with a confirmed diagnosis of celiac disease, and (2) healthy controls matched by age and sex. Participants in the celiac disease group are recruited from the Pediatric Unit of IRCCS Ospedale San Raffaele and must have a diagnosis established according to ESPGHAN guidelines; a subset diagnosed within the previous 6 months will be included in a longitudinal follow-up. Healthy controls are recruited from outpatient pediatric clinics and local schools and must have no chronic medical conditions requiring dietary therapy. All participants must be able to understand Italian and complete self-report questionnaires, with a caregiver available to complete the parent-report instrument.
Key inclusion criteria (9 listed)
- Celiac Disease Group (Cases)
- Adolescents aged 11 to 17 years
- Confirmed diagnosis of celiac disease according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy)
- Ability to understand and complete questionnaires in Italian
- For the longitudinal cohort: diagnosis < 6 months prior to enrollment
Key exclusion criteria (3 listed)
- Significant cognitive impairment or developmental disorders preventing questionnaire completion
- Inadequate understanding of the Italian language
- Refusal or inability to provide assent/consent
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
Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores
Time frame: Baseline (cross-sectional assessment)
Eating disorder psychopathology will be assessed using the YEDE-Q, completed by the adolescent. This tool evaluates restraint, eating concern, shape concern, and weight concern. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores
Time frame: Baseline (cross-sectional assessment)
Eating disorder psychopathology will be assessed using the PEDE-Q, completed by a caregiver. This tool evaluates restraint, eating concern, shape concern, and weight concern from the point of view of the caregiver. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
3 secondary outcomes
Associations Between Eating Psychopathology and Clinical/Psychosocial Variables
Time frame: baseline
Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)
Time frame: 6 months, 12 months, and 24 months after diagnosis
Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores)
Time frame: 6 months, 12 months, and 24 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The dataset contains sensitive information from minors regarding health status and eating psychopathology, and sharing identifiable or potentially re-identifiable data is not permitted under institutional and ethical guidelines.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Eating Behaviors, run by IRCCS San Raffaele.
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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Irene Carla Ferri, Doctor (+393209676736, ferri.chiarairene@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores (time frame: Baseline (cross-sectional assessment)). The study lists 2 primary outcomes in all. 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 16 Dec 2025.