Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)

NCT06043154 | Recruiting

• 1 other identifier: RC21_0598
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.

Conditions

Anorexia Nervosa

Keywords

microbiota, dysbiosis

Outcome Measures

Primary Outcomes (3)

• Identification of gut microbiota biomarkers - composition

  Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.

  At inclusion

• Identification of gut microbiota biomarkers - diversity and richness

  α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype

  At inclusion

• Identification of gut microbiota biomarkers - metabolites

  Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.

  At inclusion

Secondary Outcomes (7)

• Identification of the central adiposity phenotype

  At inclusion

• Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - composition

  At inclusion

• Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - diversity and richness

  At inclusion

• Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - metabolites

  At inclusion

• Variation of the composition of the gut microbiota between admission and discharge

  At discharge, anticipated average 10 weeks

Study Arms (1)

Anorexia nervosa

EXPERIMENTAL

Other: Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding

Interventions

Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding OTHER

Clinical and biological measurements, blood and stool sample collection

Also known as: Clinical and biological measurements, blood and stool sample collection

Anorexia nervosa

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Women only, due to the high influence of sex hormones and the low sex ratio of men admitted at hospital for anorexia nervosa.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Over 15 years old and 3 months.
• Admitted in the specialized department for eating disorders of CHU Nantes for refeeding.
• With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type).
• Body Mass Index at admission below 16 kilogram per square meter.
• Written informed consent for patients over 18 years old/ oral informed consent from both the patient and a legal representative for patients under 18 years old.
• Affiliated with French social security system or beneficiary from such system.

You may not qualify if:

• Pregnant and breastfeeding women.
• Who received a treatment with antibiotic/antifungal (other than local application) in the last three months.
• Who had a weight gain in the last month (5% or more of the patient's weight at admission).
• Under trusteeship or guardianship.
• Not fluent in French
• Who participate in another interventional study involving medication.
• Patients for whom stool collection or body mass composition analysis (with Dual-energy X-ray absorptiometry) couldn't be done during the first week of hospitalisation.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation de France: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Dysbiosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Marie GRALL-BRONNEC, Professor

CONTACT

+33 2 40 84 76 20; marie.bronnec@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: February 22, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

FR (1)