Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Last updated: June 3, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Depression

Treatment

Stool sample

Stool and blood samples

Clinical Study ID

NCT05632497
APHP211375
2021-A02529-32
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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

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, diabetesand 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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Stool sample
Phase:
Study Start date:
May 23, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

    Villejuif, 94800
    France

    Active - Recruiting

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