Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa (ANOSTOOL)

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.

Study Overview

• Status: Withdrawn
• Conditions: Anorexia Nervosa; Eating Disorder
• Intervention / Treatment: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic test: neuropsychological tests

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• anorexia nervosa with and without hunger
• constitutional leanness
• control subjects

Description

Inclusion criteria common to all four groups

• Patient affiliated or entitled to a social security scheme
• Patient who received informed information about the study
• Patient does not object to participating in the study

Inclusion criteria specific to mental anorexia

• BMI between 13 and 17.5 kg/m2
• Diagnostic and Statistical Manual of Mental Disorders IV restrictive anorexia nervosa diagnostic criteria
• Evolution of the troubles since less than 1 year.
• with feeling of hunger: "hunger" = total score on the 24-hour hunger scale > 15 and presence of the three prandial peaks (score = 3)
• having lost the feeling of hunger: "not hungry" = total score on the 24-hour hunger scale ≤ 5 and absence of the three prandial peaks (score ≤ 2)

Inclusion criteria specific to constitutionally thin patients

• BMI between 13 and 17.5 kg/m2
• Stable weight for at least 3 months
• No eating disorder
• No markers of undernutrition

Inclusion criteria specific to normal weight subjects

• 20 kg/m2 ≤ BMI ≤ 25 kg/m2
• Stable weight for at least 3 months
• No eating disorder
• No markers of undernutrition

Non-inclusion criteria for all subjects :

• Antibiotic treatment during the 2 months preceding the sampling.
• History of immune system/autoimmune disease: Immune deficiency, Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, psoriasis, Behçet's disease, celiac disease, type I diabetes.
• History of metabolic pathology: intestinal malabsorptive disease
• Medical or surgical history deemed by the investigator to be incompatible with this study.
• Severe progressive condition other
• Pregnant woman
• Majors under guardianship or subjects deprived of their liberty by judicial or administrative decision
• Ongoing psychotropic treatment
• Progressive diarrhea (Bristol Type V and VI)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
restrictive anorexia nervosa with hunger	Biological: blood sampling; 12 ml sample; Other: stool sampling; 20 g sample; Other: urine sampling; 18 ml sample; Diagnostic test: neuropsychological tests; Go-nogo; flexibility; food stroop; implicit and explicit evaluation; Child Depression Inventory; Hamilton Depression Rating Scale
restrictive anorexia nervosa without hunger	Biological: blood sampling; 12 ml sample; Other: stool sampling; 20 g sample; Other: urine sampling; 18 ml sample; Diagnostic test: neuropsychological tests; Go-nogo; flexibility; food stroop; implicit and explicit evaluation; Child Depression Inventory; Hamilton Depression Rating Scale
constitutional thinness	Biological: blood sampling; 12 ml sample; Other: stool sampling; 20 g sample; Other: urine sampling; 18 ml sample; Diagnostic test: neuropsychological tests; Go-nogo; flexibility; food stroop; implicit and explicit evaluation; Child Depression Inventory; Hamilton Depression Rating Scale
control subjects without eating disorders	Biological: blood sampling; 12 ml sample; Other: stool sampling; 20 g sample; Other: urine sampling; 18 ml sample; Diagnostic test: neuropsychological tests; Go-nogo; flexibility; food stroop; implicit and explicit evaluation; Child Depression Inventory; Hamilton Depression Rating Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
determination of bacterial microbiological profile by 16s sequencing of stool samples	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the metabolomic profile	evaluated by mass spectrometry (MS/MS) of urine	at inclusion
Neurocognitive evaluation	evaluated with questionnaire go-nogo	at 2 months
Neurocognitive evaluation	evaluated with questionnaire of flexibility	at 2 months
Neurocognitive evaluation	evaluated with questionnaire : food troop	at 2 months
Neurocognitive evaluation	evaluated with questionnaires : implicit and explicit evaluation.	at 2 months
Psychometric scaling for thymic evaluation	evaluated with questionnaire : Child Depression Inventory	at 2 months
Psychometric scaling for thymic evaluation	evaluated with questionnaire : Hamilton Depression Rating Scale	at 2 months
Determination of the plasma profile of intestinal physiology markers and immunological markers	Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin	at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers	immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein	at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers	circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4.	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Natacha GERMAIN, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: constitutional thinness; stool
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: 18CH109; 2018-A01731-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No