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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorEsther Nova

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

158 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Esther Nova

Lead sponsor

Spanish National Research Council

Sponsor institution

Spanish National Research Council (ICTAN, CSIC)

Collaborator

FUNDACION PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL INFANTIL UNIVERSITARIO NIÑO JESUS

Collaborator