NCT05632497 Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
| NCT ID | NCT05632497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Anorexia Nervosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-05-23 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Mouna HANACHI GUIDOUM, MD
PRINCIPAL INVESTIGATOR
Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
Frequently Asked Questions
Who can join the NCT05632497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05632497 currently recruiting?
Yes, NCT05632497 is actively recruiting participants. Contact the research team at mouna.hanachi@aphp.fr for enrollment information.
Where is the NCT05632497 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT05632497 clinical trial?
NCT05632497 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Mouna HANACHI GUIDOUM, MD at Service de Nutrition Clinique, Hôpital Paul Brousse - APHP. The trial plans to enroll 120 participants.