Anorexia NervosaINT-METAVOSANCT05632497
Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
An observational study of Anorexia Nervosa and Dysbiosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Dysbiosis, Anxious Depression
- What is being tested?
- Stool and blood samples
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients with anorexia nervosa for nutrition rehabilitation in the department of nutrition in Paul Brousse hospital (Villejuif) - APHP.
Who may be able to join
- For patients:
- Patients aged ≥18 years;
- Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);
- Body mass index (BMI) (P/T2) < 15;
- Hospitalization for nutrition rehabilitation;
- Covered by a health insurance;
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- Informed consent form signed.
- For Healthy Volunteers:
- Aged ≥18 years;
- 18.5 < BMI (P/T2) < 25;
- Covered by a health insurance;
- Informed consent form signed.
Who cannot join
- For patients:
- Patients no-responding all criteria of DSM-5 or CIDI scores;
- Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization;
- Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);
- Patients under guardianship;
- Patients covered by french AME scheme.
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- For Healthy Volunteers:
- Any disease should perturb intestinal microbiota;
- Recent ponderal variation;
- Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization;
- Under guardianship;
- Covered by french AME scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)
Villejuif, 94800
About this study
Official title: Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).
Read the detailed description
This is a monocentric study aims to characterise the intestinal microbiota of anorexia nervosa patients with malnutrition, in comparison with the control subject, by DNA sequencing and metagenomic method. The interaction of intetinal microbiota with the host will be studied through the mecanistic studies and various parameters of alteration of symbiosis (intestinal permeability, inflammation) and their association with psychic symptoms of anorexia nervosa.
The objective of this approche is to have not only a descrition of genomic of material of sampling, but also an overview of its potential functioning.
- Conditions
- Anorexia Nervosa, Dysbiosis, Anxious Depression
- Being tested
- Stool and blood samples
- Keywords
- Anorexia nervosa, Dysbiosis, Anxious depression, Intestinal microbiota, Body mass index
- Medical subject headings
- Anorexia Nervosa, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool and blood samplesBiological
Stool and blood samples
| Study group | Role | What they receive |
|---|---|---|
| Anorexia patients | Hospitalized anorexia patients with body mass index < 15. Receives: Biological: Stool and blood samples | |
| Healthy controls | Health volunteers: 18 years or older with body mass index between 18.5 and 25. Receives: Biological: Stool and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder
By Eating Disorder Inventory (EDI-3)
Measured: at baseline
Anxio-depressive symptomatologic assessements by HAD score
By HAD score
Measured: at baseline
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
By scale of Beck BDI 13
Measured: at baseline
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
By LSAS Lieboweitz social anxiety scale
Measured: at baseline
Anxio-depressive symptomatologic assessements by MOCI
By Maudsley Obsessions and compulsions inventory (MOCI).
Measured: at baseline
Anxio-depressive symptomatologic assessements
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Measured: at baseline
Physical exercise
By Global physical activity questionnaire (GPAQ)
Measured: at baseline
Biological parameter
By serum serotonin level
Measured: at baseline
Secondary outcomes (16)
Diversity indice
By index de Sympson et Shannon
Measured: at baseline
Intestinal permeability
By serum zonulin level
Measured: at baseline
Immunity alteration
By interleukins and CRP level
Measured: at baseline
Liver function
Cytolyse analysis in serum
Measured: at baseline
BMI
Calculate of BMI.
Measured: at baseline
Body composition
By Dexa-Scan.
Measured: at baseline
Energy expenditure
Calculate of indirect calorimetry and blood parameters
Measured: at baseline
Intestinal functional disorders
By Francis scale, ,transit with pellets and abdomen x-ray
Measured: at baseline
Gene and species richness
By 16S rRNA gene sequencing method and Metagenomics
Measured: at baseline
Circulating mitochondrial DNA copy number
By telemore size and HLA genotyping
Measured: at baseline
Heart damage
By Left Ventricle Ejection Fraction < 50% structural parameters on ultrasound
Measured: at baseline
Presence of Autistic symptoms (1)
By Glasgow Sensory Questionnaire GSQ)
Measured: at baseline
Presence of Autistic symptoms (2)
By The SWedish Eating Assessment for Autism spectrum disorders GSQ)
Measured: at baseline
EDI
QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)
Measured: at baseline
Eating Disorder Diagnostic
By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)
Measured: at baseline
Eating behaviors assessment
By the Detail and Flexibility Questionnaire (DFlex).
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start23 May 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Mouna HANACHI GUIDOUM, MD, Principal investigator, Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632497
- Sponsor's protocol ID
- APHP211375
- Other IDs
- 2021-A02529-32
- Acronym
- INT-METAVOSA
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2022
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
- ClinicalTrials.gov ID
- NCT05632497
- Acronym / sponsor ID
- INT-METAVOSA / APHP211375
- Conditions
- Anorexia Nervosa, Dysbiosis, Anxious Depression
- Keywords
- Anorexia nervosa, Dysbiosis, Anxious depression, Intestinal microbiota, Body mass index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 23 May 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Nov 2022 (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.
The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).
Detailed description
This is a monocentric study aims to characterise the intestinal microbiota of anorexia nervosa patients with malnutrition, in comparison with the control subject, by DNA sequencing and metagenomic method. The interaction of intetinal microbiota with the host will be studied through the mecanistic studies and various parameters of alteration of symbiosis (intestinal permeability, inflammation) and their association with psychic symptoms of anorexia nervosa.
The objective of this approche is to have not only a descrition of genomic of material of sampling, but also an overview of its potential functioning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia patients | – | Biological: Stool and blood samplesHospitalized anorexia patients with body mass index < 15. |
| Healthy controls | – | Biological: Stool and blood samplesHealth volunteers: 18 years or older with body mass index between 18.5 and 25. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with anorexia nervosa for nutrition rehabilitation in the department of nutrition in Paul Brousse hospital (Villejuif) - APHP.
Key inclusion criteria (12 listed)
- Patients aged ≥18 years;
- Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);
- Body mass index (BMI) (P/T2) < 15;
- Hospitalization for nutrition rehabilitation;
- Covered by a health insurance;
Key exclusion criteria (12 listed)
- Patients no-responding all criteria of DSM-5 or CIDI scores;
- Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization;
- Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);
- Patients under guardianship;
- Patients covered by french AME scheme.
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 |
|---|---|---|
| Stool and blood samplesStool and blood samples | Biological | Anorexia patients, Healthy controls |
Primary outcome
Eating Disorder
Time frame: at baseline
By Eating Disorder Inventory (EDI-3)
Anxio-depressive symptomatologic assessements by HAD score
Time frame: at baseline
By HAD score
Anxio-depressive symptomatologic assessements by scale of Beck BDI 13
Time frame: at baseline
By scale of Beck BDI 13
Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale
Time frame: at baseline
By LSAS Lieboweitz social anxiety scale
Anxio-depressive symptomatologic assessements by MOCI
Time frame: at baseline
By Maudsley Obsessions and compulsions inventory (MOCI).
Anxio-depressive symptomatologic assessements
Time frame: at baseline
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Physical exercise
Time frame: at baseline
By Global physical activity questionnaire (GPAQ)
Biological parameter
Time frame: at baseline
By serum serotonin level
16 secondary outcomes
Diversity indice
Time frame: at baseline
Intestinal permeability
Time frame: at baseline
Immunity alteration
Time frame: at baseline
Liver function
Time frame: at baseline
BMI
Time frame: at baseline
Body composition
Time frame: at baseline
Energy expenditure
Time frame: at baseline
Intestinal functional disorders
Time frame: at baseline
Gene and species richness
Time frame: at baseline
Circulating mitochondrial DNA copy number
Time frame: at baseline
Heart damage
Time frame: at baseline
Presence of Autistic symptoms (1)
Time frame: at baseline
Presence of Autistic symptoms (2)
Time frame: at baseline
EDI
Time frame: at baseline
Eating Disorder Diagnostic
Time frame: at baseline
Eating behaviors assessment
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
Mouna HANACHI GUIDOUM, MD principal investigator
Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Dysbiosis, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mouna HANACHI GUIDOUM, MD (+ 33 6 70 39 42 37, mouna.hanachi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder (time frame: at baseline). The study lists 8 primary outcomes in all. 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 24 Nov 2025.