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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Dysbiosis
Anorexia Nervosa
Anxious Depression

Treatments

Biological: Stool and blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT05632497
APHP211375
2021-A02529-32 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Anorexia patients
Description:
Hospitalized anorexia patients with body mass index \< 15.
Treatment:
Biological: Stool and blood samples
Healthy controls
Description:
Health volunteers: 18 years or older with body mass index between 18.5 and 25.
Treatment:
Biological: Stool and blood samples

Trial contacts and locations

1

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Central trial contact

Joël DORE; Mouna HANACHI GUIDOUM, MD

Data sourced from clinicaltrials.gov

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