Intestinal microbiota in children and adolescents with eating disorders — a psychoneuroimmunology perspective
Getting Into the Guts of Eating Disorders in Children and Adolescents. A Perspective From Psychoneuroimmunology.
Spanish National Research Council · NCT07066033
This project will test whether the mix and activity of gut bacteria differ in children and adolescents with eating disorders and whether those differences relate to diet, symptoms, or one-year treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 158 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Spanish National Research Council (other gov) |
| Locations | 2 sites (Madrid, Madrid and 1 other locations) |
| Trial ID | NCT07066033 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children and adolescents aged 7.0–17.9 years with a DSM‑5 diagnosis of anorexia nervosa (restrictive or binge–purge), OSFED, or ARFID with first episode or symptom duration under one year and parental/adolescent consent.
Not a fit: Patients with long-standing or previously unsuccessfully treated eating disorders, current infections, certain endocrine or gastrointestinal diseases, severe neurodevelopmental disorders, or recent suicidal behavior are excluded and unlikely to benefit from the study results.
Why it matters
Potential benefit: If successful, the study could identify gut microbiota patterns linked to symptoms or prognosis that help target future personalized interventions or guide diet-based support.
How similar studies have performed: Prior adult and some pediatric studies have reported microbiota differences in eating disorders but findings have been inconsistent and remain largely exploratory, so this approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eating Disorders in Adolescence, Eating Disorders in Children, Eating disorders, psychopathology, intestinal microbiota, diettary pattern, neuroendocrine peptides, neurotransmitters