Investigating the Role of Gut Microbiota in Anorexia Nervosa
Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
This study is testing how the bacteria in the gut might affect weight gain fears and fat distribution in people with severe anorexia nervosa during their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06043154 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between gut microbiota and the central adiposity phenotype in patients with anorexia nervosa during refeeding. It aims to understand how the composition and products of gut microbiota may influence patients' fears of weight gain and the distribution of fat in the body. Patients with severe to extreme anorexia nervosa will undergo clinical examinations and stool analysis to identify potential biomarkers linked to their condition. The findings could provide insights into the mechanisms affecting treatment resistance and relapse in anorexia nervosa.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 15 years old with a diagnosis of severe to extreme anorexia nervosa who are admitted for refeeding.
Not a fit: Patients who are pregnant, breastfeeding, or have recently gained weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for anorexia nervosa by addressing underlying biological factors related to gut health.
How similar studies have performed: While the investigation of gut microbiota in anorexia nervosa is a relatively novel approach, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Nantes
- Nantes University Hospital — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Marie GRALL-BRONNEC, Professor
- Email: marie.bronnec@chu-nantes.fr
- Phone: +33 2 40 84 76 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.