Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

Study Overview
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Brief Summary
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This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

Detailed Description
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Eating disorders are a public health issue. It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake. A recent study of laboratory INSERM 1073 showed the existence of an intestinal bacterial protein exhibiting structural similarities with α-MSH: ClpB. The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc. To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed. This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Nutritional modulations (probiotic, amino-acid…) could constitute an interesting therapeutic perspective in the future.

Official Title
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Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

Conditions
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Eating Disorder

Intervention / Treatment
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* Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with eating disorders 18 Years and older first clinical visit in nutrition department of CHU de Rouen for eating disorders anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V social security Affiliation Patient who signed the MEC approved informed consent Volunteers 18 Years to 60 Years body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2 negative SCOFF test No active and history of eating disorders social security Affiliation volunteer who signed the MEC approved informed consent Exclusion criteria: Patients with eating disorders No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V Adults under legal protection or under safeguard of justice or administrative decision Pregnancy Volunteers Active or history of eating disorder Adults under legal protection or under safeguard of justice or administrative decision Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eating disorders compared to healthy volonteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eating disorders patients<br>first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V | Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation<br>* blood samples (12ml) and stool samples (30g) collections<br>* Other names: Factors associated with eating disorders;|
| Other: healthy volunteers<br>Volunteers with negative SCOFF test (No active or history of eating disorders) | Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation<br>* blood samples (12ml) and stool samples (30g) collections<br>* Other names: Factors associated with eating disorders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders | blood samples collections | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for determination factors associated with eating disorders | A global scale will evaluate : socio demographic factors somatic and psychiatric comorbidities addictions personal and family antecedents major events | 1 week | 
| statute in autoantibody and behavioral characteristics of the eating disorder | quality of life and the psychological state of the patients tests | 1 week | 
| Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders | stoll samples collections | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoantibodies (autoAc) circulating, neuropeptides (Ghrelin, l'α-MSH), potential digestive origin