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

ConditionsEating Disorders in Adolescence Eating Disorders in Children

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

This trial accepts healthy volunteers

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 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

158 Participants

are grouped into 2 trial groups

Group A: Eating disorder patients

Group B: Control group

Trial outcomes

Primary outcomes

Intestinal microbiota composition

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

Time frame

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.

Time frame

Baseline

Secondary outcomes

Hematology

White blood cells (WBC) and differential.

Time frame

baseline

Routine biochemistry

Glucose, hepatic enzymes (GOT, GPT, gamma-GT), urea, creatinine, uric acid, total bilirubin; C-reactive protein, lipid profile (Cholesterol, HDL-cho, LDL-cho, VLDL-cho).

Time frame

Baseline

Hormones, gastrointestinal and adipose tissue peptides

Insulin, Cortisol, Leptin, active Ghrelin, Total PYY, active GLP-1; and Adiponectin.

Time frame

Baseline

Systemic Inflammation

plasma inflammatory cytokines (MCP-1, IL-2; IL-1beta, IL-6, TNF-alfa; IL-10); markers of intestinal permeability mediators of inflammation, such as LPS-binding protein (LPB) and zonulin-1.

Time frame

Baseline

Other outcomes

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

In participating patients a second stool sample with be collected after one year of treatment in order to compare data on microbiota composition with baseline results.

Time frame

Baseline and 12 months