Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Eating Disorder
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Anorexia patients
Hospitalized anorexia patients with body mass index < 15.
Intervention: Stool and blood samples (Biological)
Healthy controls
Health volunteers: 18 years or older with body mass index between 18.5 and 25.
Intervention: Stool and blood samples (Biological)
Outcomes
Primary Outcomes
Eating Disorder
Time Frame: at baseline
By Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD score
Time Frame: at baseline
By HAD score
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
Time Frame: at baseline
By LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements
Time Frame: at baseline
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exercise
Time Frame: at baseline
By Global physical activity questionnaire (GPAQ)
Biological parameter
Time Frame: at baseline
By serum serotonin level
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
Time Frame: at baseline
By scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by MOCI
Time Frame: at baseline
By Maudsley Obsessions and compulsions inventory (MOCI).
Secondary Outcomes
- Immunity alteration(at baseline)
- EDI(at baseline)
- Gene and species richness(at baseline)
- Circulating mitochondrial DNA copy number(at baseline)
- Presence of Autistic symptoms (1)(at baseline)
- Eating Disorder Diagnostic(at baseline)
- Diversity indice(at baseline)
- Intestinal permeability(at baseline)
- Liver function(at baseline)
- BMI(at baseline)
- Body composition(at baseline)
- Intestinal functional disorders(at baseline)
- Energy expenditure(at baseline)
- Heart damage(at baseline)
- Presence of Autistic symptoms (2)(at baseline)
- Eating behaviors assessment(at baseline)