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)

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

Study Overview

• Status: Unknown
• Conditions: Eating Disorder
• Intervention / Treatment: Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling 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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Najate EL MACHKOURI ACHAMRAH, MD, PhD; Phone Number: +33 2 32 88 57 05; Email: Najate.Achamrah@chu-rouen.fr
• Study Contact Backup: Name: Pierre DECHELOTTE, Pr; Phone Number: +33 2 32 88 64 65; Email: Pierre.Dechelotte@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • Centre d'Investigation Clinique
    • Contact: Marie-Pierre TAVOLACCI, Ph, D; Phone Number: +33 2 32 88 88 62; Email: MP.Tavolacci@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eating disorders patients; 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; blood samples (12ml) and stool samples (30g) collections; Other Names: Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB; Factors associated with eating disorders
Other: healthy volunteers; 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; blood samples (12ml) and stool samples (30g) collections; Other Names: Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB; Factors associated with eating disorders

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Najate EL MACHKOURI ACHAMRAH, MD, PhD, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: autoantibodies (autoAc) circulating; neuropeptides (Ghrelin, l'α-MSH); potential digestive origin
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Physiological Effects of Drugs; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Autoantibodies; alpha-MSH
• Other Study ID Numbers: 2016/107/HP; 2017-A00875-48 (Other Identifier: Agence Nationale de Sécurité du médicament et des produits de Santé)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No