Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa (NCT05632497) | Clinical Trial Compass
RecruitingNot Applicable
Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
France120 participantsStarted 2024-05-23
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eating Disorder
Timeframe: at baseline
2
Anxio-depressive symptomatologic assessements by HAD score
Timeframe: at baseline
3
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
Timeframe: at baseline
4
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
Timeframe: at baseline
5
Anxio-depressive symptomatologic assessements by MOCI