Eating DisorderEDILS-AutoACNCT03510533
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
A study of Eating Disorder, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2018to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.
Read the 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
- Being tested
- Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation
- Keywords
- autoantibodies (autoAc) circulating, neuropeptides (Ghrelin, l'α-MSH), potential digestive origin
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulationOther
Also called Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB, Factors associated with eating disorders
blood samples (12ml) and stool samples (30g) collections
| Study group | Role | What they receive |
|---|---|---|
| Eating disorders patients | Experimental | first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V Receives: Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation |
| healthy volunteers | Other | Volunteers with negative SCOFF test (No active or history of eating disorders) Receives: Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (3)
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
Measured: 1 week
statute in autoantibody and behavioral characteristics of the eating disorder
quality of life and the psychological state of the patients tests
Measured: 1 week
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders
stoll samples collections
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start24 May 2018
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Eating disorders compared to healthy volonteers
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Najate EL MACHKOURI ACHAMRAH, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510533
- Sponsor's protocol ID
- 2016/0107/HP
- Other IDs
- 2017-A00875-48
- Acronym
- EDILS-AutoAC
- Status last verified
- Feb 2026
- First submitted
- 4 Apr 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03510533
- Acronym / sponsor ID
- EDILS-AutoAC / 2016/0107/HP
- Conditions
- Eating Disorder
- Keywords
- autoantibodies (autoAc) circulating, neuropeptides (Ghrelin, l'α-MSH), potential digestive origin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eating disorders compared to healthy volonteers
| Arm | Type | Receives |
|---|---|---|
| Eating disorders patients | Experimental | Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulationfirst clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V |
| healthy volunteers | Other | Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulationVolunteers with negative SCOFF test (No active or history of eating disorders) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulationAlso: Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB, Factors associated with eating disordersblood samples (12ml) and stool samples (30g) collections | Other | Eating disorders patients, healthy volunteers |
Primary outcome
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
3 secondary outcomes
Scale for determination factors associated with eating disorders
Time frame: 1 week
statute in autoantibody and behavioral characteristics of the eating disorder
Time frame: 1 week
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najate EL MACHKOURI ACHAMRAH, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Eating Disorder, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.