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Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05632497
Acronym
INT-METAVOSA
Enrollment
120
Registered
2022-11-30
Start date
2024-05-23
Completion date
2026-10-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Anxious Depression, Dysbiosis

Keywords

Anorexia nervosa, Dysbiosis, Anxious depression, Intestinal microbiota, Body mass index

Brief 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).

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

Stool and blood samples

Sponsors

Fondation de France
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Eating Disorderat baselineBy Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD scoreat baselineBy HAD score
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13at baselineBy scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scaleat baselineBy LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements by MOCIat baselineBy Maudsley Obsessions and compulsions inventory (MOCI).
Anxio-depressive symptomatologic assessementsat baselineBy HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exerciseat baselineBy Global physical activity questionnaire (GPAQ)
Biological parameterat baselineBy serum serotonin level

Secondary

MeasureTime frameDescription
Gene and species richnessat baselineBy 16S rRNA gene sequencing method and Metagenomics
Circulating mitochondrial DNA copy numberat baselineBy telemore size and HLA genotyping
Heart damageat baselineBy Left Ventricle Ejection Fraction \< 50% structural parameters on ultrasound
Presence of Autistic symptoms (1)at baselineBy Glasgow Sensory Questionnaire GSQ)
Diversity indiceat baselineBy index de Sympson et Shannon
EDIat baselineQUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)
Eating Disorder Diagnosticat baselineBy Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)
Eating behaviors assessmentat baselineBy the Detail and Flexibility Questionnaire (DFlex).
Presence of Autistic symptoms (2)at baselineBy The SWedish Eating Assessment for Autism spectrum disorders GSQ)
Intestinal permeabilityat baselineBy serum zonulin level
Immunity alterationat baselineBy interleukins and CRP level
Liver functionat baselineCytolyse analysis in serum
BMIat baselineCalculate of BMI.
Body compositionat baselineBy Dexa-Scan.
Energy expenditureat baselineCalculate of indirect calorimetry and blood parameters
Intestinal functional disordersat baselineBy Francis scale, ,transit with pellets and abdomen x-ray

Countries

France

Contacts

Primary ContactMouna HANACHI GUIDOUM, MD
mouna.hanachi@aphp.fr+ 33 6 70 39 42 37
Backup ContactJoël DORE
joel.dore@jouy.inrae.fr+ 33 1 34 65 27 09

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026