Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05632497

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

F

Fondation de France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how changes in the intestinal microbiota, including disruptions in its balance and increased gut permeability, relate to psychic symptoms in people with anorexia nervosa (AN), such as food restriction intensity, anxiety, and depression. This observational study aims to compare the gut microbiota and host environment interactions between patients with malnutrition from AN and healthy individuals. The goal is to understand not only the genetic makeup of the microbiota but also its potential functions and how these relate to symptoms of AN. The study involves two groups: hospitalized anorexia patients with a body mass index (BMI) under 15, and healthy volunteers aged 18 or older with a BMI between 18.5 and 25. Researchers will collect stool and blood samples to analyze the microbiota using DNA sequencing and metagenomic methods. They will also assess intestinal permeability, inflammation, immunity changes, and other biological markers to explore the relationship between the gut environment and psychic symptoms. Participants will undergo evaluations at baseline, including assessments of eating disorders, anxiety, depression, physical exercise, and various biological and metabolic parameters. Researchers will also measure gut microbiota diversity, body composition, liver function, energy expenditure, and other health indicators. These comprehensive assessments aim to clarify how alterations in gut microbiota relate to AN symptoms and overall health. The study is expected to continue until October 2026.

CONDITIONS

Brief Title

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For patients: aged 18 years or older
  • Diagnosis of anorexia nervosa according to DSM-5 and CIDI
  • Body mass index less than 15
  • Hospitalized for nutritional rehabilitation
  • Covered by health insurance
  • Signed informed consent form
  • For healthy volunteers: aged 18 years or older
  • Body mass index between 18.5 and 25
  • Covered by health insurance
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Patients not meeting all DSM-5 or CIDI criteria
  • Use of antibiotic treatment within 2 months or laxatives within 3 weeks before hospitalization
  • Presence of chronic inflammatory diseases affecting intestinal microbiota (e.g., Crohn's disease, diabetes)
  • Patients under legal guardianship
  • Patients covered by French AME scheme
  • Healthy volunteers with diseases affecting intestinal microbiota
  • Recent significant weight changes
  • Use of antibiotic treatment within 2 months or laxatives within 3 weeks before hospitalization
  • Under legal guardianship
  • Covered by French AME scheme

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single baseline assessment

Participants provide stool and blood samples and undergo assessments to characterize intestinal microbiota and evaluate eating disorder and anxio-depressive symptoms.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion in October 2026

Participants are observed for ongoing study of intestinal microbiota and associated symptoms without active intervention.

Visits as needed for sample collection and assessments

Trial Site Locations

Total: 1 location

1

Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

Villejuif, France, 94800

Actively Recruiting

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Research Team

M

Mouna HANACHI GUIDOUM, MD

J

Joël DORE

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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