Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Recruiting

• Conditions: Anorexia Nervosa; Dysbiosis; Anxious Depression
• Interventions: Biological: Stool and blood samples

• Registration Number: NCT05632497
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-30
• Status Verified: 2024-05
• Study Start: 2024-05-23
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Stool and blood samples	Health volunteers: 18 years or older with body mass index between 18.5 and 25.
Anorexia patients	Stool and blood samples	Hospitalized anorexia patients with body mass index \< 15.

Primary Outcome Measures

Name	Time	Method
Eating Disorder	at baseline	By Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD score	at baseline	By HAD score
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale	at baseline	By LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements	at baseline	By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exercise	at baseline	By Global physical activity questionnaire (GPAQ)
Biological parameter	at baseline	By serum serotonin level
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13	at baseline	By scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by MOCI	at baseline	By Maudsley Obsessions and compulsions inventory (MOCI).

Secondary Outcome Measures

Name	Time	Method
Immunity alteration	at baseline	By interleukins and CRP level
EDI	at baseline	QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)
Gene and species richness	at baseline	By 16S rRNA gene sequencing method and Metagenomics
Circulating mitochondrial DNA copy number	at baseline	By telemore size and HLA genotyping
Presence of Autistic symptoms (1)	at baseline	By Glasgow Sensory Questionnaire GSQ)
Eating Disorder Diagnostic	at baseline	By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)
Diversity indice	at baseline	By index de Sympson et Shannon
Intestinal permeability	at baseline	By serum zonulin level
Liver function	at baseline	Cytolyse analysis in serum
BMI	at baseline	Calculate of BMI.
Body composition	at baseline	By Dexa-Scan.
Intestinal functional disorders	at baseline	By Francis scale, ,transit with pellets and abdomen x-ray
Energy expenditure	at baseline	Calculate of indirect calorimetry and blood parameters
Heart damage	at baseline	By Left Ventricle Ejection Fraction \< 50% structural parameters on ultrasound
Presence of Autistic symptoms (2)	at baseline	By The SWedish Eating Assessment for Autism spectrum disorders GSQ)
Eating behaviors assessment	at baseline	By the Detail and Flexibility Questionnaire (DFlex).

Trial Locations

Locations (1)

Service de Nutrition Clinique, Hôpital Paul Brousse (APHP); 🇫🇷 Villejuif, France