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

NCT ID: NCT03510533

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-24
• Study Completion Date: 2025-08-13

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.

Conditions

Eating Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation

Intervention Type: OTHER

blood samples (12ml) and stool samples (30g) collections

healthy volunteers

Volunteers with negative SCOFF test (No active or history of eating disorders)

Group Type: OTHER

Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation

Intervention Type: OTHER

blood samples (12ml) and stool samples (30g) collections

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB; Factors associated with eating disorders

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Najate EL MACHKOURI ACHAMRAH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Centre d'Investigation Clinique

Rouen, , France

Countries

France

Other Identifiers

2017-A00875-48

Identifier Type: OTHER

Identifier Source: secondary_id

2016/0107/HP

Identifier Type: -

Identifier Source: org_study_id