Examining the gut microbiota in patients with anorexia nervosa

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

This study looks at how the gut bacteria of people with anorexia nervosa differs from those who are healthy to see if these changes are linked to their symptoms and overall health.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Villejuif)
• Trial ID: NCT05632497 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between the severity of anorexia nervosa symptoms and alterations in the intestinal microbiota. It will involve characterizing the gut microbiota of malnourished anorexia nervosa patients compared to healthy controls using DNA sequencing and metagenomic methods. The study will also explore how changes in the microbiota may affect intestinal permeability, inflammation, and psychiatric symptoms associated with anorexia nervosa.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of anorexia nervosa and a BMI of less than 15 who are hospitalized for nutritional rehabilitation.

Not a fit: Patients with other chronic inflammatory diseases or those who have recently taken antibiotics or laxatives may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of the gut-brain connection in anorexia nervosa, potentially informing new treatment strategies.

How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a potential link between gut microbiota and psychiatric conditions, suggesting a promising area of investigation.

Eligibility criteria

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.

Where this trial is running

Villejuif

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

Study contacts

• Principal investigator: Mouna HANACHI GUIDOUM, MD — Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
• Study coordinator: Mouna HANACHI GUIDOUM, MD

Conditions: Anorexia Nervosa, Dysbiosis, Anxious Depression, Anorexia nervosa, Anxious depression, Intestinal microbiota, Body mass index