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Completed

NCT Number: NCT03510533

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique

Rouen, 76031, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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
  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EDILS-AutoAC

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2018
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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