Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07066033
Eligibility Criteria:
Inclusion Criteria:
* Age: 7-17.9 years
* Diagnosis of Anorexia Nervosa, both restrictive (ANR) and binge-purging (ANBP) subtypes, Other Specified Feeding and Eating Disorders (OSFED), Avoidant/Restrictive Food Intake Disorder (ARFID) according to DSM-V (APA, 2013).
* Males and females
* First episode or less than 1 year evolution since initial symptoms
* Written informed consent by parent/tutor and also by the adolescent if age is more than 12 y.
Exclusion Criteria:
* Comorbidities: Current infectious disease at admission; Severe neurodevelopmental disorders with impaired language development; Moderate or severe intellectual disability; Endocrine disorders such as diabetes mellitus or thyroid disease; Celiac disease; Suicidal behaviors in the previous 3 months.
* Patients with previous unsuccessful treatments for more than one year.
* Use of the following medications before entering the study: laxatives, anabolic steroids, immunosuppressant drugs, Helicobacter pylori eradication treatment, thyroid hormones or antibiotic treatment in the previous two months
* Surgery in the previous month. Control group participants' exclusion criteria are the same plus the following: History with diagnosis of mental disease (including EDs). Current autoimmune or infectious disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT07066033
Study Brief:
Protocol Section:
NCT07066033