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

NCT03736642 | Withdrawn

• 2 other identifiers: 18CH1092018-A01731-54
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Eating Disorder

Keywords

stool; constitutional thinness

Outcome Measures

Primary Outcomes (1)

• determination of bacterial microbiological profile by 16s sequencing of stool samples

  at inclusion

Secondary Outcomes (10)

• Determination of the metabolomic profile

  at inclusion

• Neurocognitive evaluation

  at 2 months

• Neurocognitive evaluation

  at 2 months

• Neurocognitive evaluation

  at 2 months

• Neurocognitive evaluation

  at 2 months

Study Arms (4)

restrictive anorexia nervosa with hunger

Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests

restrictive anorexia nervosa without hunger

Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests

constitutional thinness

Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests

control subjects without eating disorders

Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests

Interventions

blood sampling BIOLOGICAL

12 ml sample

constitutional thinness; control subjects without eating disorders; restrictive anorexia nervosa with hunger; restrictive anorexia nervosa without hunger

stool sampling OTHER

20 g sample

constitutional thinness; control subjects without eating disorders; restrictive anorexia nervosa with hunger; restrictive anorexia nervosa without hunger

urine sampling OTHER

18 ml sample

constitutional thinness; control subjects without eating disorders; restrictive anorexia nervosa with hunger; restrictive anorexia nervosa without hunger

neuropsychological tests DIAGNOSTIC_TEST

* Go-nogo * flexibility * food stroop * implicit and explicit evaluation * Child Depression Inventory * Hamilton Depression Rating Scale

constitutional thinness; control subjects without eating disorders; restrictive anorexia nervosa with hunger; restrictive anorexia nervosa without hunger

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: only female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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)
• BMI between 13 and 17.5 kg/m2
• Stable weight for at least 3 months
• No eating disorder
• No markers of undernutrition
• kg/m2 ≤ BMI ≤ 25 kg/m2
• Stable weight for at least 3 months
• No eating disorder

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* 20 g of stool * 18 ml of urines * 12 ml of blood

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Natacha GERMAIN

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 9, 2018
• Study Start: May 15, 2019
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)