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A Study of the Intestinal Microbiota in Children and Adolescents With Eating Disorders. A Perspective From Psychoneuroimmunology

Recruitingn/aAges 7 Years - 18 YearsAllEsther Nova
NCT07066033 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn if behavioral and psychological factors are associated with the intestinal microbiota composition and function in children and adolescents with eating disorders (ED). The main questions it aims to answer are: * Are there any differences between the microbiota composition and function in adolescent patients with eating disorders and healthy adolescents? * Are the dietary pattern and other lifestyle habits associated with the intestinal microbiota composition in patients with a recent onset eating disorder? * Is it possible to predict the treatment response at one year by looking at any of the psychological and biological factors measured in the patients at baseline? * Are there any differences in the intestinal microbiota among patients with different subtypes of anorexia nervosa (restrictive, binge-purging, atypical) or with avoidance/res

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Institute of Food Science and Technology and Nutrition (ICTAN, CSIC)
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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