INT-METAVOSA: Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05632497

Collaborator

Fondation de France (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa Dysbiosis Anxious Depression	Biological: Stool sample

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

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Anorexia patients Hospitalized anorexia patients with body mass index < 15.	Biological: Stool sample Stool sample
Healthy controls Health volunteers: 18 years or older with body mass index between 18.5 and 25.	Biological: Stool sample Stool sample

Arm

Intervention/Treatment

Anorexia patients

Hospitalized anorexia patients with body mass index < 15.

Biological: Stool sample

Stool sample

Healthy controls

Health volunteers: 18 years or older with body mass index between 18.5 and 25.

Biological: Stool sample

Stool sample

Outcome Measures

Primary Outcome Measures

Eating Disorder [at baseline]
By Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD score [at baseline]
By HAD score
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13 [at baseline]
By scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale [at baseline]
By LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements by MOCI [at baseline]
By Maudsley Obsessions and compulsions inventory (MOCI).
Anxio-depressive symptomatologic assessements [at baseline]
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exercise [at baseline]
By Global physical activity questionnaire (GPAQ)
Biological parameter [at baseline]
By serum serotonin level

Secondary Outcome Measures

Diversity indice [at baseline]
By index de Sympson et Shannon
Intestinal permeability [at baseline]
By serum zouulin level
Immunity alteration [at baseline]
By interleukin 6 level
Liver function [at baseline]
Cytolyse analysis in serum
BMI [at baseline]
Calculate of BMI
Intestinal functional disorders [at baseline]
By Francis scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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.