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

NCT07066033 | Recruiting

• 1 other identifier: PID2022-136588OB-C21
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

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

Eating Disorders in Adolescence; Eating Disorders in Children

Keywords

Eating disorders; psychopathology; intestinal microbiota; diettary pattern; neuroendocrine peptides; neurotransmitters; inflammation; short chain fatty acids; metagenomics; prognostic factors

Outcome Measures

Primary Outcomes (2)

• Intestinal microbiota composition

  Intestinal microbiota composition as derived from Shot-gun metagenomics with deep-sequencing analysis will be used on stool isolated DNA.

  Baseline

• Intestinal microbiota function

  Microbial metabolites will be analyzed in fecal water, including SCFA by gas chromatography-FID and aminoacids and neurotransmitters (GABA, dopamine, serotonin) by HPLC.

  Baseline

Secondary Outcomes (4)

• Hematology

  baseline

• Routine biochemistry

  Baseline

• Hormones, gastrointestinal and adipose tissue peptides

  Baseline

• Systemic Inflammation

  Baseline

Other Outcomes (1)

• Change from baseline in fecal microbial taxa quantified by shotgun metagenomics with deep sequencing analysis

  Baseline and 12 months

Study Arms (2)

Eating disorder patients

Children and adolescents with a recent onset eating disorder initiating treatment in a Specialized Eating Disorder Unit

Control group

Healthy children and adolescents matched by age and sex with the ED patients

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients will be recruited in the ED specialized unit of the Niño Jesus University Children Hospital (NJUCH) after receiving a DSM-V ED diagnosis by an experienced psychiatrist. Patients will be eligible on treatment modalities including hospitalization, outpatient consultations or home hospitalization. The control group will be recruited among healthy children and adolescents attending eligible levels in private and public centers of formal education. Eligible educational centers are those located in geographical areas included in the administrative health zones assigned to the NJUCH. A combination of private and public schools from both metropolitan and peripheral cities is being selected. Invitation letters are sent to the head of the schools and following acceptance, randomization of age levels across schools is performed.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Esther Nova: lead
• Spanish National Research Council (ICTAN, CSIC): collaborator
• FUNDACION PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL INFANTIL UNIVERSITARIO NIÑO JESUS: collaborator

Study Sites (2)

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, 28009, Spain

RECRUITING

Institute of Food Science and Technology and Nutrition (ICTAN, CSIC)

Madrid, Madrid, 28040, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and stool samples will be stored beyond the end of the project for a maximum period of five years. Pseudonymised samples may be used for further analyses of the same nature only if the volunteer has given consent for their use beyond the present project. Only the use by the same research team responsible for the present project will be allowed.

MeSH Terms

Conditions

Feeding and Eating Disorders; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Study Officials

• Esther Nova, PhD

  Spanish National Research Council (CSIC - ICTAN)

  STUDY CHAIR

• Mar Faya, PhD, MD

  Hospital Infantil Universitario Niño Jesús

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Nova, PhD

CONTACT

34 5492300; enova@ictan.csic.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 15, 2025
• Study Start: August 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication with no end date

Locations

ES (2)