Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders (EDILS-AutoAC)
Primary Purpose
Eating Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
Sponsored by
About this trial
This is an interventional health services research trial for Eating Disorder focused on measuring autoantibodies (autoAc) circulating, neuropeptides (Ghrelin, l'α-MSH), potential digestive origin
Eligibility Criteria
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
Sites / Locations
- Centre d'Investigation Clinique
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Eating disorders patients
healthy volunteers
Arm Description
first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V
Volunteers with negative SCOFF test (No active or history of eating disorders)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
statute in autoantibody and behavioral characteristics of the eating disorder
quality of life and the psychological state of the patients tests
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders
stoll samples collections
Full Information
NCT ID
NCT03510533
First Posted
April 4, 2018
Last Updated
April 26, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT03510533
Brief Title
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Acronym
EDILS-AutoAC
Official Title
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
autoantibodies (autoAc) circulating, neuropeptides (Ghrelin, l'α-MSH), potential digestive origin
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eating disorders compared to healthy volonteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eating disorders patients
Arm Type
Experimental
Arm Description
first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V
Arm Title
healthy volunteers
Arm Type
Other
Arm Description
Volunteers with negative SCOFF test (No active or history of eating disorders)
Intervention Type
Other
Intervention Name(s)
Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
Other Intervention Name(s)
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB, Factors associated with eating disorders
Intervention Description
blood samples (12ml) and stool samples (30g) collections
Primary Outcome Measure Information:
Title
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
Description
blood samples collections
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Scale for determination factors associated with eating disorders
Description
A global scale will evaluate :
socio demographic factors
somatic and psychiatric comorbidities
addictions
personal and family antecedents
major events
Time Frame
1 week
Title
statute in autoantibody and behavioral characteristics of the eating disorder
Description
quality of life and the psychological state of the patients tests
Time Frame
1 week
Title
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders
Description
stoll samples collections
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najate EL MACHKOURI ACHAMRAH, MD, PhD
Phone
2 32 88 57 05
Ext
+33
Email
Najate.Achamrah@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre DECHELOTTE, Pr
Phone
2 32 88 64 65
Ext
+33
Email
Pierre.Dechelotte@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najate EL MACHKOURI ACHAMRAH, MD, PhD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre TAVOLACCI, Ph, D
Phone
2 32 88 88 62
Ext
+33
Email
MP.Tavolacci@chu-rouen.fr
12. IPD Sharing Statement
Learn more about this trial
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
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