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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03736642
Acronym
ANOSTOOL
Enrollment
0
Registered
2018-11-09
Start date
2019-05-15
Completion date
2019-05-15
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Eating Disorder

Keywords

stool, constitutional thinness

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.

Interventions

OTHERstool sampling

20 g sample

18 ml sample

BIOLOGICALblood sampling

12 ml sample

DIAGNOSTIC_TESTneuropsychological tests

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
determination of bacterial microbiological profile by 16s sequencing of stool samplesat inclusion

Secondary

MeasureTime frameDescription
Determination of the metabolomic profileat inclusionevaluated by mass spectrometry (MS/MS) of urine
Neurocognitive evaluationat 2 monthsevaluated with questionnaire go-nogo
Psychometric scaling for thymic evaluationat 2 monthsevaluated with questionnaire : Child Depression Inventory
Determination of the plasma profile of intestinal physiology markers and immunological markersat inclusionIntestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026