Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

Withdrawn

• Conditions: Anorexia Nervosa; Eating Disorder
• Interventions: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests

• Registration Number: NCT03736642
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2019-05-15
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
restrictive anorexia nervosa without hunger	urine sampling	-
restrictive anorexia nervosa without hunger	neuropsychological tests	-
control subjects without eating disorders	blood sampling	-
restrictive anorexia nervosa with hunger	urine sampling	-
restrictive anorexia nervosa with hunger	blood sampling	-
restrictive anorexia nervosa with hunger	stool sampling	-
restrictive anorexia nervosa without hunger	blood sampling	-
control subjects without eating disorders	stool sampling	-
control subjects without eating disorders	urine sampling	-
restrictive anorexia nervosa with hunger	neuropsychological tests	-
restrictive anorexia nervosa without hunger	stool sampling	-
constitutional thinness	blood sampling	-
constitutional thinness	stool sampling	-
constitutional thinness	urine sampling	-
constitutional thinness	neuropsychological tests	-
control subjects without eating disorders	neuropsychological tests	-

Primary Outcome Measures

Name	Time	Method
determination of bacterial microbiological profile by 16s sequencing of stool samples	at inclusion

Secondary Outcome Measures

Name	Time	Method
Determination of the metabolomic profile	at inclusion	evaluated by mass spectrometry (MS/MS) of urine
Neurocognitive evaluation	at 2 months	evaluated with questionnaires : implicit and explicit evaluation.
Psychometric scaling for thymic evaluation	at 2 months	evaluated with questionnaire : Hamilton Depression Rating Scale
Determination of the plasma profile of intestinal physiology markers and immunological markers	at inclusion	circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Etienne, France