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

Eating Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03510533
• Other study ID #: 2016/107/HP
• Secondary ID: 2017-A00875-48
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2018
• Last updated: April 26, 2018
• Start date: May 2018
• Est. completion date: January 2021

Study information

• Verified date: April 2018
• Source: University Hospital, Rouen
• Contact: Najate EL MACHKOURI ACHAMRAH, MD, PhD
• Phone: 2 32 88 57 05
• Email: Najate.Achamrah[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: January 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Patients with eating disorders

1. 18 Years and older

2. first clinical visit in nutrition department of CHU de Rouen for eating disorders

3. anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V

4. social security Affiliation

5. Patient who signed the MEC approved informed consent

Volunteers

1. 18 Years to 60 Years

2. body mass index = 18,5 kg/m2 and = 24,9 kg/m2

3. negative SCOFF test

4. No active and history of eating disorders

5. social security Affiliation

6. volunteer who signed the MEC approved informed consent

Exclusion criteria:

Patients with eating disorders

1. No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V

2. Adults under legal protection or under safeguard of justice or administrative decision

3. Pregnancy

Volunteers

1. Active or history of eating disorder

2. Adults under legal protection or under safeguard of justice or administrative decision

3. Pregnancy

Related Conditions & MeSH terms

• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Other:
• Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
blood samples (12ml) and stool samples (30g) collections

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	statute in autoantibody and behavioral characteristics of the eating disorder	quality of life and the psychological state of the patients tests	1 week
Secondary	Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders	stoll samples collections	1 week