Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— INT-METAVOSA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632497
• Other study ID #: APHP211375
• Secondary ID: 2021-A02529-32
• Status: Recruiting
• Start date: May 23, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mouna HANACHI GUIDOUM, MD
• Phone: + 33 6 70 39 42 37
• Email: mouna.hanachi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anxious Depression
• Depression
• Depressive Disorder
• Dysbiosis

Intervention

Biological:
• Stool and blood samples
Stool and blood samples

Locations

Country	Name	City	State
France	Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorder	By Eating Disorder Inventory (EDI-3)	at baseline
Primary	Anxio-depressive symptomatologic assessements by HAD score	By HAD score	at baseline
Primary	Anxio-depressive symptomatologic assessements by scale of Beck BDI 13	By scale of Beck BDI 13	at baseline
Primary	Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale	By LSAS Lieboweitz social anxiety scale	at baseline
Primary	Anxio-depressive symptomatologic assessements by MOCI	By Maudsley Obsessions and compulsions inventory (MOCI).	at baseline
Primary	Anxio-depressive symptomatologic assessements	By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).	at baseline
Primary	Physical exercise	By Global physical activity questionnaire (GPAQ)	at baseline
Primary	Biological parameter	By serum serotonin level	at baseline
Secondary	Diversity indice	By index de Sympson et Shannon	at baseline
Secondary	Intestinal permeability	By serum zonulin level	at baseline
Secondary	Immunity alteration	By interleukins and CRP level	at baseline
Secondary	Liver function	Cytolyse analysis in serum	at baseline
Secondary	BMI	Calculate of BMI.	at baseline
Secondary	Body composition	By Dexa-Scan.	at baseline
Secondary	Energy expenditure	Calculate of indirect calorimetry and blood parameters	at baseline
Secondary	Intestinal functional disorders	By Francis scale, ,transit with pellets and abdomen x-ray	at baseline
Secondary	Gene and species richness	By 16S rRNA gene sequencing method and Metagenomics	at baseline
Secondary	Circulating mitochondrial DNA copy number	By telemore size and HLA genotyping	at baseline
Secondary	Heart damage	By Left Ventricle Ejection Fraction < 50% structural parameters on ultrasound	at baseline
Secondary	Presence of Autistic symptoms (1)	By Glasgow Sensory Questionnaire GSQ)	at baseline
Secondary	Presence of Autistic symptoms (2)	By The SWedish Eating Assessment for Autism spectrum disorders GSQ)	at baseline
Secondary	EDI	QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)	at baseline
Secondary	Eating Disorder Diagnostic	By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)	at baseline
Secondary	Eating behaviors assessment	By the Detail and Flexibility Questionnaire (DFlex).	at baseline