Actively Recruiting
Getting Into the Guts of Eating Disorders in Children and Adolescents. A Perspective From Psychoneuroimmunology.
Led by Esther Nova · Updated on 2025-07-15
158
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
E
Esther Nova
Lead Sponsor
S
Spanish National Research Council (ICTAN, CSIC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring whether behavioral and psychological factors are linked to the types and functions of bacteria in the intestines of children and adolescents with eating disorders (ED). The study focuses on differences in gut microbiota between young patients with ED and healthy peers, dietary and lifestyle influences on gut bacteria, and whether these factors can predict treatment response after one year. It also examines gut microbiota differences among various ED subtypes including anorexia nervosa and avoidant/restrictive food intake disorder (ARFID). The study involves two groups: children and adolescents recently diagnosed with an eating disorder and healthy participants matched by age and sex. Participants with ED will complete lifestyle and psychological questionnaires, undergo body measurements, and provide blood and stool samples at the start and after one year. Healthy participants will provide similar data only at baseline. Stool samples will be analyzed for bacteria types and functions using advanced DNA sequencing techniques. Participants will share detailed medical, psychiatric, and lifestyle histories through interviews and questionnaires. Researchers will measure body composition, blood markers related to hormones and inflammation, and analyze stool for gut bacteria and metabolites. Psychological tests will assess eating disorder symptoms and related mental health conditions. The main outcomes measured are gut microbiota composition and function at baseline, with follow-up after one year for patients. The study aims to improve understanding of gut-related factors in eating disorders to support personalized treatment approaches.
CONDITIONS
Brief Title
A Study of the Intestinal Microbiota in Children and Adolescents With Eating Disorders. A Perspective From Psychoneuroimmunology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 7 and 17.9 years
- Diagnosis of anorexia nervosa (restrictive or binge-purging), other specified feeding and eating disorders, or avoidant/restrictive food intake disorder according to DSM-V
- Male or female
- First episode or less than 1 year since initial symptoms
- Written informed consent from parent or guardian and adolescent if over 12 years old
You will not qualify if you...
- 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
- Previous unsuccessful treatments for more than one year
- Use of laxatives, anabolic steroids, immunosuppressant drugs, Helicobacter pylori eradication treatment, thyroid hormones, or antibiotics in the previous two months
- Surgery in the previous month
- For healthy controls: history of mental disease including eating disorders, current autoimmune or infectious disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit
Participants undergo interviews and assessments including developmental, medical, psychiatric history, psychometric tests, dietary study, and biomarker analyses to evaluate intestinal microbiota and related factors.
1 visit (in-person)
Duration - 1 year after baseline
One year after initial assessments, participants with eating disorders are re-evaluated with the same procedures to check changes in microbiota composition and study prognostic factors.
1 follow-up visit (in-person) after 1 year
Trial Site Locations
Total: 2 locations
1
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain, 28009
Actively Recruiting
2
Institute of Food Science and Technology and Nutrition (ICTAN, CSIC)
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
E
Esther Nova, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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