Actively Recruiting

Age: 7Years - 18Years
All Genders
Healthy Volunteers
NCT07066033

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

Led by Esther Nova · Updated on 2025-07-15

158

Participants Needed

2

Research Sites

152 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

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/restrictive food intake disorder (ARFID)? Researchers will compare the results with those obtained from a group of healthy children and adolescents matched by sex and age to find out if the associations observed differ between ED and control participants. Participants with ED will fill in different lifestyle questionnaires and psychological tests; they will also undergo anthropometrical measurements and will provide fecal and blood samples at baseline and one year later. Healthy participants will provide the same lifestyle information, anthopometrical measurements and stool and blood samples. They will only undergo the baseline evaluation.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
  • Both males and females
  • First episode or symptoms evolving for less than one year
  • Written informed consent from parent or guardian and from adolescent if older than 12 years
Not Eligible

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 lasting more than one year
  • Use of laxatives, anabolic steroids, immunosuppressants, Helicobacter pylori eradication treatment, thyroid hormones, or antibiotics within the last two months
  • Surgery in the previous month
  • (For control group) History of mental disease including eating disorders
  • (For control group) Current autoimmune or infectious disease

AI-Screening

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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

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Research Team

E

Esther Nova, PhD

CONTACT

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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