Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)
Villejuif, 94800, France
Location status: Recruiting
NCT Number: NCT05632497
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Villejuif, 94800, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For patients:
For Healthy Volunteers:
Exclusion criteria
For patients:
For Healthy Volunteers:
Stool and blood samples
Time frame: at baseline
By Eating Disorder Inventory (EDI-3)
Time frame: at baseline
By HAD score
Time frame: at baseline
By scale of Beck BDI 13
Time frame: at baseline
By LSAS Lieboweitz social anxiety scale
Time frame: at baseline
By Maudsley Obsessions and compulsions inventory (MOCI).
Time frame: at baseline
By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI).
Time frame: at baseline
By Global physical activity questionnaire (GPAQ)
Time frame: at baseline
By serum serotonin level
Time frame: at baseline
By index de Sympson et Shannon
Time frame: at baseline
By serum zonulin level
Time frame: at baseline
By interleukins and CRP level
Time frame: at baseline
Cytolyse analysis in serum
Time frame: at baseline
Calculate of BMI.
Time frame: at baseline
By Dexa-Scan.
Time frame: at baseline
Calculate of indirect calorimetry and blood parameters
Time frame: at baseline
By Francis scale, ,transit with pellets and abdomen x-ray
Time frame: at baseline
By 16S rRNA gene sequencing method and Metagenomics
Time frame: at baseline
By telemore size and HLA genotyping
Time frame: at baseline
By Left Ventricle Ejection Fraction < 50% structural parameters on ultrasound
Time frame: at baseline
By Glasgow Sensory Questionnaire GSQ)
Time frame: at baseline
By The SWedish Eating Assessment for Autism spectrum disorders GSQ)
Time frame: at baseline
QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2)
Time frame: at baseline
By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals)
Time frame: at baseline
By the Detail and Flexibility Questionnaire (DFlex).
Contact information is provided by the study sponsor or research team.
Joël DORE
CONTACT
Mouna HANACHI GUIDOUM, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)
Acronym: INT-METAVOSA
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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