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

Anorexia Nervosa Clinical Trial

— ANOSTOOL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03736642
• Other study ID #: 18CH109
• Secondary ID: 2018-A01731-54
• Status: Withdrawn
• Start date: May 15, 2019
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Biological:
• blood sampling
12 ml sample

Other:
• stool sampling
20 g sample
• 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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of bacterial microbiological profile by 16s sequencing of stool samples		at inclusion
Secondary	Determination of the metabolomic profile	evaluated by mass spectrometry (MS/MS) of urine	at inclusion
Secondary	Neurocognitive evaluation	evaluated with questionnaire go-nogo	at 2 months
Secondary	Neurocognitive evaluation	evaluated with questionnaire of flexibility	at 2 months
Secondary	Neurocognitive evaluation	evaluated with questionnaire : food troop	at 2 months
Secondary	Neurocognitive evaluation	evaluated with questionnaires : implicit and explicit evaluation.	at 2 months
Secondary	Psychometric scaling for thymic evaluation	evaluated with questionnaire : Child Depression Inventory	at 2 months
Secondary	Psychometric scaling for thymic evaluation	evaluated with questionnaire : Hamilton Depression Rating Scale	at 2 months
Secondary	Determination of the plasma profile of intestinal physiology markers and immunological markers	Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin	at inclusion
Secondary	Determination of the plasma profile of intestinal physiology markers and immunological markers	immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein	at inclusion
Secondary	Determination of the plasma profile of intestinal physiology markers and immunological markers	circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1ß, IL 22, IL21, IL33, IL31, TNFa, IFN?, IL9, IL10, IL4.	at inclusion