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

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ClinicalTrials.gov Identifier: NCT03736642
Recruitment Status : Not yet recruiting
First Posted : November 9, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Anorexia Nervosa Eating Disorder Biological: blood sampling Other: stool sampling Other: urine sampling Diagnostic Test: neuropsychological tests

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. determination of bacterial microbiological profile by 16s sequencing of stool samples [ Time Frame: at inclusion ]

Secondary Outcome Measures :
  1. Determination of the metabolomic profile [ Time Frame: at inclusion ]
    evaluated by mass spectrometry (MS/MS) of urine

  2. Neurocognitive evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaire go-nogo

  3. Neurocognitive evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaire of flexibility

  4. Neurocognitive evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaire : food troop

  5. Neurocognitive evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaires : implicit and explicit evaluation.

  6. Psychometric scaling for thymic evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaire : Child Depression Inventory

  7. Psychometric scaling for thymic evaluation [ Time Frame: at 2 months ]
    evaluated with questionnaire : Hamilton Depression Rating Scale

  8. Determination of the plasma profile of intestinal physiology markers and immunological markers [ Time Frame: at inclusion ]
    Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin

  9. Determination of the plasma profile of intestinal physiology markers and immunological markers [ Time Frame: at inclusion ]
    immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein

  10. Determination of the plasma profile of intestinal physiology markers and immunological markers [ Time Frame: at inclusion ]
    circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4.


Biospecimen Retention:   Samples With DNA
  • 20 g of stool
  • 18 ml of urines
  • 12 ml of blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • anorexia nervosa with and without hunger
  • constitutional leanness
  • control subjects
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736642


Contacts
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Contact: Natacha GERMAIN 0477127727 ext +33 natacha.germain@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Not yet recruiting
Saint-Etienne, France, 42055
Contact: Natacha GERMAIN    0477127727 ext +33    natacha.germain@chu-st-etienne.fr   
Sub-Investigator: Bogdan GALUSCA, MD         
Sub-Investigator: Stéphane PAUL, MD         
Principal Investigator: Natacha GERMAIN, PU-PH         
Sub-Investigator: Catherine MASSOUBRE, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Natacha GERMAIN CHU de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03736642     History of Changes
Other Study ID Numbers: 18CH109
2018-A01731-54 ( Other Identifier: ANSM )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
stool
constitutional thinness
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms