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NCT Number: NCT05632497

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

Villejuif, 94800, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool and blood samples

Biological

Stool and blood samples

Primary outcomes

  1. Eating Disorder

    Time frame: at baseline

    By Eating Disorder Inventory (EDI-3)

  2. Anxio-depressive symptomatologic assessements by HAD score

    Time frame: at baseline

    By HAD score

  3. Anxio-depressive symptomatologic assessements by scale of Beck BDI 13

    Time frame: at baseline

    By scale of Beck BDI 13

  4. Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale

    Time frame: at baseline

    By LSAS Lieboweitz social anxiety scale

  5. Anxio-depressive symptomatologic assessements by MOCI

    Time frame: at baseline

    By Maudsley Obsessions and compulsions inventory (MOCI).

  6. 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).

  7. Physical exercise

    Time frame: at baseline

    By Global physical activity questionnaire (GPAQ)

  8. Biological parameter

    Time frame: at baseline

    By serum serotonin level

Secondary outcomes

  1. Diversity indice

    Time frame: at baseline

    By index de Sympson et Shannon

  2. Intestinal permeability

    Time frame: at baseline

    By serum zonulin level

  3. Immunity alteration

    Time frame: at baseline

    By interleukins and CRP level

  4. Liver function

    Time frame: at baseline

    Cytolyse analysis in serum

  5. BMI

    Time frame: at baseline

    Calculate of BMI.

  6. Body composition

    Time frame: at baseline

    By Dexa-Scan.

  7. Energy expenditure

    Time frame: at baseline

    Calculate of indirect calorimetry and blood parameters

  8. Intestinal functional disorders

    Time frame: at baseline

    By Francis scale, ,transit with pellets and abdomen x-ray

  9. Gene and species richness

    Time frame: at baseline

    By 16S rRNA gene sequencing method and Metagenomics

  10. Circulating mitochondrial DNA copy number

    Time frame: at baseline

    By telemore size and HLA genotyping

  11. Heart damage

    Time frame: at baseline

    By Left Ventricle Ejection Fraction < 50% structural parameters on ultrasound

  12. Presence of Autistic symptoms (1)

    Time frame: at baseline

    By Glasgow Sensory Questionnaire GSQ)

  13. Presence of Autistic symptoms (2)

    Time frame: at baseline

    By The SWedish Eating Assessment for Autism spectrum disorders GSQ)

  14. EDI

    Time frame: at baseline

    QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)

  15. Eating Disorder Diagnostic

    Time frame: at baseline

    By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)

  16. Eating behaviors assessment

    Time frame: at baseline

    By the Detail and Flexibility Questionnaire (DFlex).

Study contacts

Contact information is provided by the study sponsor or research team.

Joël DORE

CONTACT

[email protected]

+ 33 1 34 65 27 09

Mouna HANACHI GUIDOUM, MD

CONTACT

[email protected]

+ 33 6 70 39 42 37

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de France

Registry information

Official study 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)

Acronym: INT-METAVOSA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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