Clinical trial NCT05632497: Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
Official title: Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Dysbiosis
Anxious Depression
Keywords: Anorexia nervosa
Dysbiosis
Anxious depression
Intestinal microbiota
Body mass index
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2022-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with anorexia nervosa for nutrition rehabilitation in the department of nutrition in Paul Brousse hospital (Villejuif) - APHP.

Brief summary: The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

Detailed description: This is a monocentric study aims to characterise the intestinal microbiota of anorexia nervosa patients with malnutrition, in comparison with the control subject, by DNA sequencing and metagenomic method. The interaction of intetinal microbiota with the host will be studied through the mecanistic studies and various parameters of alteration of symbiosis (intestinal permeability, inflammation) and their association with psychic symptoms of anorexia nervosa.

The objective of this approche is to have not only a descrition of genomic of material of sampling, but also an overview of its potential functioning.

Eligibility criteria: Inclusion Criteria:

For patients:

* Patients aged ≥18 years;
* Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);
* Body mass index (BMI) (P/T2) \< 15;
* Hospitalization for nutrition rehabilitation;
* Covered by a health insurance;
* Informed consent form signed.

For Healthy Volunteers:

* Aged ≥18 years;
* 18.5 \< BMI (P/T2) \< 25;
* Covered by a health insurance;
* Informed consent form signed.

Exclusion Criteria:

For patients:

* Patients no-responding all criteria of DSM-5 or CIDI scores;
* Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization;
* Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);
* Patients under guardianship;
* Patients covered by french AME scheme.

For Healthy Volunteers:

* Any disease should perturb intestinal microbiota;
* Recent ponderal variation;
* Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization;
* Under guardianship;
* Covered by french AME scheme.

Primary outcomes:
measure: Eating Disorder
timeFrame: at baseline
measure: Anxio-depressive symptomatologic assessements by HAD score
timeFrame: at baseline
measure: Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
timeFrame: at baseline
measure: Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
timeFrame: at baseline
measure: Anxio-depressive symptomatologic assessements by MOCI
timeFrame: at baseline
measure: Anxio-depressive symptomatologic assessements
timeFrame: at baseline
measure: Physical exercise
timeFrame: at baseline
measure: Biological parameter
timeFrame: at baseline
Secondary outcomes:
measure: Diversity indice
timeFrame: at baseline
measure: Intestinal permeability
timeFrame: at baseline
measure: Immunity alteration
timeFrame: at baseline
measure: Liver function
timeFrame: at baseline
measure: BMI
timeFrame: at baseline
measure: Body composition
timeFrame: at baseline
measure: Energy expenditure
timeFrame: at baseline
measure: Intestinal functional disorders
timeFrame: at baseline
measure: Gene and species richness
timeFrame: at baseline
measure: Circulating mitochondrial DNA copy number
timeFrame: at baseline
measure: Heart damage
timeFrame: at baseline
measure: Presence of Autistic symptoms (1)
timeFrame: at baseline
measure: Presence of Autistic symptoms (2)
timeFrame: at baseline
measure: EDI
timeFrame: at baseline
measure: Eating Disorder Diagnostic
timeFrame: at baseline
measure: Eating behaviors assessment
timeFrame: at baseline
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)
Study officials:
affiliation: Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
name: Mouna HANACHI GUIDOUM, MD
role: PRINCIPAL_INVESTIGATOR
References: