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)

February 4, 2026 updated by: University Hospital, Rouen
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

Completed

Conditions

Intervention / Treatment

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 (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Centre d'investigation Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 week
blood samples collections
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale for determination factors associated with eating disorders
Time Frame: 1 week

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
Time Frame: 1 week
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
Time Frame: 1 week
stoll samples collections
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Najate EL MACHKOURI ACHAMRAH, MD, PhD, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2018

Primary Completion (Actual)

August 13, 2025

Study Completion (Actual)

August 13, 2025

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)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/0107/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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