Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.

Official Title
-----------------
Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa, Eating Disorder

Intervention / Treatment
-----------------
* Biological: blood sampling
* Other: stool sampling
* Other: urine sampling
* Diagnostic Test: neuropsychological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria common to all four groups Patient affiliated or entitled to a social security scheme Patient who received informed information about the study Patient does not object to participating in the study Inclusion criteria specific to mental anorexia BMI between 13 and 17.5 kg/m2 Diagnostic and Statistical Manual of Mental Disorders IV restrictive anorexia nervosa diagnostic criteria Evolution of the troubles since less than 1 year. with feeling of hunger: hunger = total score on the 24-hour hunger scale > 15 and presence of the three prandial peaks (score = 3) having lost the feeling of hunger: not hungry = total score on the 24-hour hunger scale ≤ 5 and absence of the three prandial peaks (score ≤ 2) Inclusion criteria specific to constitutionally thin patients BMI between 13 and 17.5 kg/m2 Stable weight for at least 3 months No eating disorder No markers of undernutrition Inclusion criteria specific to normal weight subjects 20 kg/m2 ≤ BMI ≤ 25 kg/m2 Stable weight for at least 3 months No eating disorder No markers of undernutrition Non-inclusion criteria for all subjects : Antibiotic treatment during the 2 months preceding the sampling. History of immune system/autoimmune disease: Immune deficiency, Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, psoriasis, Behçet's disease, celiac disease, type I diabetes. History of metabolic pathology: intestinal malabsorptive disease Medical or surgical history deemed by the investigator to be incompatible with this study. Severe progressive condition other Pregnant woman Majors under guardianship or subjects deprived of their liberty by judicial or administrative decision Ongoing psychotropic treatment Progressive diarrhea (Bristol Type V and VI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| restrictive anorexia nervosa with hunger<br> | Biological: blood sampling<br>* 12 ml sample<br>Other: stool sampling<br>* 20 g sample<br>Other: urine sampling<br>* 18 ml sample<br>Diagnostic Test: neuropsychological tests<br>* Go-nogo flexibility food stroop implicit and explicit evaluation Child Depression Inventory Hamilton Depression Rating Scale<br>|
| restrictive anorexia nervosa without hunger<br> | Biological: blood sampling<br>* 12 ml sample<br>Other: stool sampling<br>* 20 g sample<br>Other: urine sampling<br>* 18 ml sample<br>Diagnostic Test: neuropsychological tests<br>* Go-nogo flexibility food stroop implicit and explicit evaluation Child Depression Inventory Hamilton Depression Rating Scale<br>|
| constitutional thinness<br> | Biological: blood sampling<br>* 12 ml sample<br>Other: stool sampling<br>* 20 g sample<br>Other: urine sampling<br>* 18 ml sample<br>Diagnostic Test: neuropsychological tests<br>* Go-nogo flexibility food stroop implicit and explicit evaluation Child Depression Inventory Hamilton Depression Rating Scale<br>|
| control subjects without eating disorders<br> | Biological: blood sampling<br>* 12 ml sample<br>Other: stool sampling<br>* 20 g sample<br>Other: urine sampling<br>* 18 ml sample<br>Diagnostic Test: neuropsychological tests<br>* Go-nogo flexibility food stroop implicit and explicit evaluation Child Depression Inventory Hamilton Depression Rating Scale<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of bacterial microbiological profile by 16s sequencing of stool samples |  | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the metabolomic profile | evaluated by mass spectrometry (MS/MS) of urine | at inclusion | 
| Neurocognitive evaluation | evaluated with questionnaire go-nogo | at 2 months | 
| Neurocognitive evaluation | evaluated with questionnaire of flexibility | at 2 months | 
| Neurocognitive evaluation | evaluated with questionnaire : food troop | at 2 months | 
| Neurocognitive evaluation | evaluated with questionnaires : implicit and explicit evaluation. | at 2 months | 
| Psychometric scaling for thymic evaluation | evaluated with questionnaire : Child Depression Inventory | at 2 months | 
| Psychometric scaling for thymic evaluation | evaluated with questionnaire : Hamilton Depression Rating Scale | at 2 months | 
| Determination of the plasma profile of intestinal physiology markers and immunological markers | Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin | at inclusion | 
| Determination of the plasma profile of intestinal physiology markers and immunological markers | immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein | at inclusion | 
| Determination of the plasma profile of intestinal physiology markers and immunological markers | circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4. | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stool, constitutional thinness