Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05632497
Other study ID # APHP211375
Secondary ID 2021-A02529-32
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2024
Est. completion date July 2025

Study information

Verified date May 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Mouna HANACHI GUIDOUM, MD
Phone + 33 6 70 39 42 37
Email mouna.hanachi@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 permeability, immunity alteration and low-grade inflammation).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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; - 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. Exclusion Criteria: 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. 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.

Study Design


Intervention

Biological:
Stool and blood samples
Stool and blood samples

Locations

Country Name City State
France Service de Nutrition Clinique, Hôpital Paul Brousse (APHP) Villejuif

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Disorder By Eating Disorder Inventory (EDI-3) at baseline
Primary Anxio-depressive symptomatologic assessements by HAD score By HAD score at baseline
Primary Anxio-depressive symptomatologic assessements by scale of Beck BDI 13 By scale of Beck BDI 13 at baseline
Primary Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale By LSAS Lieboweitz social anxiety scale at baseline
Primary Anxio-depressive symptomatologic assessements by MOCI By Maudsley Obsessions and compulsions inventory (MOCI). at baseline
Primary Anxio-depressive symptomatologic assessements By HAD score, scale of Beck BDI 13, LSAS Lieboweitz social anxiety scale, Maudsley Obsessions and compulsions inventory (MOCI). at baseline
Primary Physical exercise By Global physical activity questionnaire (GPAQ) at baseline
Primary Biological parameter By serum serotonin level at baseline
Secondary Diversity indice By index de Sympson et Shannon at baseline
Secondary Intestinal permeability By serum zonulin level at baseline
Secondary Immunity alteration By interleukins and CRP level at baseline
Secondary Liver function Cytolyse analysis in serum at baseline
Secondary BMI Calculate of BMI. at baseline
Secondary Body composition By Dexa-Scan. at baseline
Secondary Energy expenditure Calculate of indirect calorimetry and blood parameters at baseline
Secondary Intestinal functional disorders By Francis scale, ,transit with pellets and abdomen x-ray at baseline
Secondary Gene and species richness By 16S rRNA gene sequencing method and Metagenomics at baseline
Secondary Circulating mitochondrial DNA copy number By telemore size and HLA genotyping at baseline
Secondary Heart damage By Left Ventricle Ejection Fraction < 50% structural parameters on ultrasound at baseline
Secondary Presence of Autistic symptoms (1) By Glasgow Sensory Questionnaire GSQ) at baseline
Secondary Presence of Autistic symptoms (2) By The SWedish Eating Assessment for Autism spectrum disorders GSQ) at baseline
Secondary EDI QUESTIONNAIRE EDI or EATING DISORDER INVENTORY (Eating disorder inventory 2nd edition (EDI-2) at baseline
Secondary Eating Disorder Diagnostic By Eating Disorder Diagnostic Scale (EDDS)-DSM-5 VERSION (2015 Wiley Periodicals) at baseline
Secondary Eating behaviors assessment By the Detail and Flexibility Questionnaire (DFlex). at baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05531604 - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Active, not recruiting NCT04883554 - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study N/A
Recruiting NCT04213820 - TMS and Body Image Treatment for Anorexia Nervosa N/A
Completed NCT03414112 - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa Early Phase 1
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Recruiting NCT05803707 - Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study N/A
Recruiting NCT05682417 - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa N/A
Not yet recruiting NCT06380257 - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting NCT04804800 - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa N/A
Not yet recruiting NCT03600610 - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa N/A
Completed NCT02745067 - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa N/A
Completed NCT02382055 - Changing Habits in Anorexia Nervosa: Novel Treatment Development N/A
Completed NCT03075371 - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa N/A
Terminated NCT02240797 - Kappa Opioid Receptor Imaging in Anorexia N/A
Unknown status NCT01761942 - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa Phase 2
Completed NCT03144986 - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa N/A
Completed NCT01579682 - Adaptive Family Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT02551445 - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. N/A
Completed NCT00946816 - The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity N/A