Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

NCT ID: NCT05632497

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-23

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa Dysbiosis Anxious Depression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Anorexia patients

Hospitalized anorexia patients with body mass index \< 15.

Stool and blood samples

Intervention Type BIOLOGICAL

Stool and blood samples

Healthy controls

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

Stool and blood samples

Intervention Type BIOLOGICAL

Stool and blood samples

Interventions

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Stool and blood samples

Stool and blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mouna HANACHI GUIDOUM, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Nutrition Clinique, Hôpital Paul Brousse - APHP

Locations

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Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mouna HANACHI GUIDOUM, MD

Role: CONTACT

+ 33 6 70 39 42 37

Joël DORE

Role: CONTACT

+ 33 1 34 65 27 09

Other Identifiers

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2021-A02529-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP211375

Identifier Type: -

Identifier Source: org_study_id

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