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Recruiting NCT05632497

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

— Observational Anorexia Nervosa Dysbiosis Anxious Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stool and blood samples.
Who it may be relevant to
Registry conditions: Anorexia Nervosa, Dysbiosis, Anxious Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Biological Stool and blood samples
    Stool and blood samples

Primary outcome measures

  • Eating Disorder [Time frame: at baseline]
  • Anxio-depressive symptomatologic assessements by HAD score [Time frame: at baseline]
  • Anxio-depressive symptomatologic assessements by scale of Beck BDI 13 [Time frame: at baseline]
  • Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale [Time frame: at baseline]
  • Anxio-depressive symptomatologic assessements by MOCI [Time frame: at baseline]
  • Anxio-depressive symptomatologic assessements [Time frame: at baseline]
  • Physical exercise [Time frame: at baseline]
  • Biological parameter [Time frame: at baseline]
Secondary outcome measures (12)
  • Diversity indice [Time frame: at baseline]
  • Intestinal permeability [Time frame: at baseline]
  • Immunity alteration [Time frame: at baseline]
  • Liver function [Time frame: at baseline]
  • BMI [Time frame: at baseline]
  • Body composition [Time frame: at baseline]
  • Energy expenditure [Time frame: at baseline]
  • Intestinal functional disorders [Time frame: at baseline]
  • Gene and species richness [Time frame: at baseline]
  • Circulating mitochondrial DNA copy number [Time frame: at baseline]
  • Heart damage [Time frame: at baseline]
  • Presence of Autistic symptoms (1) [Time frame: at baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Service de Nutrition Clinique, Hôpital Paul Brousse (APHP) — Villejuif

Identifiers

NCT: NCT05632497 · APHP211375 · 2021-A02529-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗