Intestinal microbiota in children and adolescents with eating disorders — a psychoneuroimmunology perspective

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort study enrolling patients aged 7 to 17.9 years with a recent-onset eating disorder to compare their intestinal microbiota composition and function with healthy peers. Researchers collect stool samples, dietary and lifestyle histories, and standardized measures of psychopathology and neuroendocrine markers at baseline, then follow clinical course to one year to see if baseline factors predict outcome. The study also compares microbiota signatures across eating disorder subtypes (AN restrictive, AN binge–purge, OSFED, ARFID). Laboratory work is done in collaboration with a national food science institute and a pediatric university hospital in Madrid.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Infantil Universitario Niño Jesús
  Madrid, Madrid, Spain Recruiting
• Institute of Food Science and Technology and Nutrition (ICTAN, CSIC)
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Mar Faya, PhD, MD — Hospital Infantil Universitario Niño Jesús
• Study coordinator: Esther Nova, PhD
• Email: enova@ictan.csic.es
• Phone: 34 5492300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.