Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

NCT05632497 | Recruiting

• 2 other identifiers: APHP2113752021-A02529-32
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Anorexia Nervosa; Dysbiosis; Anxious Depression

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• Diversity indice

  at baseline

• Intestinal permeability

  at baseline

• Immunity alteration

  at baseline

• Liver function

  at baseline

• BMI

  at baseline

Study Arms (2)

Anorexia patients

Hospitalized anorexia patients with body mass index \< 15.

Biological: Stool and blood samples

Healthy controls

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

Biological: Stool and blood samples

Interventions

Stool and blood samples BIOLOGICAL

Stool and blood samples

Anorexia patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• \< BMI (P/T2) \< 25;
• Covered by a health insurance;
• Informed consent form signed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de France: collaborator

Study Sites (1)

Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

Villejuif, 94800, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample will be collected for all of 2 types of subjects (patients and health volunteers).

MeSH Terms

Conditions

Anorexia Nervosa; Dysbiosis

Interventions

Defecation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mouna HANACHI GUIDOUM, MD

  Service de Nutrition Clinique, Hôpital Paul Brousse - APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mouna HANACHI GUIDOUM, MD

CONTACT

+ 33 6 70 39 42 37; mouna.hanachi@aphp.fr

Joël DORE

CONTACT

+ 33 1 34 65 27 09; joel.dore@jouy.inrae.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 30, 2022
• Study Start: May 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)