Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa (INT-METAVOSA)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Anorexia Nervosa; Dysbiosis; Anxious Depression
• Intervention / Treatment: Biological: Stool sample

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Mouna HANACHI GUIDOUM, MD; Phone Number: + 33 6 70 39 42 37; Email: mouna.hanachi@aphp.fr
• Study Contact Backup: Name: Joël DORE; Phone Number: + 33 1 34 65 27 09; Email: joel.dore@jouy.inrae.fr

Study Locations

• France
  • Villejuif, France, 94800
    • Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with anorexia nervosa for nutrition rehabilitation in the department of nutrition in Paul Brousse hospital (Villejuif) - APHP.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anorexia patients; Hospitalized anorexia patients with body mass index < 15.	Biological: Stool sample; Stool sample
Healthy controls; Health volunteers: 18 years or older with body mass index between 18.5 and 25.	Biological: Stool sample; Stool sample

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diversity indice	By index de Sympson et Shannon	at baseline
Intestinal permeability	By serum zouulin level	at baseline
Immunity alteration	By interleukin 6 level	at baseline
Liver function	Cytolyse analysis in serum	at baseline
BMI	Calculate of BMI	at baseline
Intestinal functional disorders	By Francis scale	at baseline

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Mouna HANACHI GUIDOUM, MD, Service de Nutrition Clinique, Hôpital Paul Brousse - APHP

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Intestinal microbiota; Body mass index; Dysbiosis; Anorexia nervosa; Anxious depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Depression; Depressive Disorder; Anorexia; Anorexia Nervosa; Dysbiosis
• Other Study ID Numbers: APHP211375; 2021-A02529-32 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No