Clinical trial NCT05842343: Food Intake and IgA Microbiota in Anorexia Nervosa
Official title: Food Intake and IgA Microbiota in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Healthy Volunteer
Keywords: anorexia nervosa
microbiota
gut-brain-axis
immunology (IgA)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)
First posted: 2023-05-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases.

Detailed description: Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Here we aim to characterize the IgA-coated fraction of bacteria from the intestinal microbiota, linked to the regulation of the mucosal immune system and the epithelium physiology. Abnormalities of this microbiota are reported in inflammatory bowel disease and are associated to immune trouble. As food intake plays a key role in shaping microbiota, we aim to correlate data from IgA microbiota to food intake specificity, and to anorexia nervosa phenotypes.

Eligibility criteria: Inclusion Criteria:

* female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne
* presenting a diagnosis of pure restrictive anorexia nervosa.

For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.

For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.

For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder

Exclusion Criteria:

* patient does not understand French.
* laxative treatment in progress or stopped for less than 15 days,
* antibiotic treatment in the two months preceding inclusion,
* pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
* patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
* subject under legal protective measures.

Primary outcomes:
measure: Total microbiotic profile
timeFrame: 1 week after inclusion
Secondary outcomes:
measure: ELISA assay of fecal immunoglobulins
timeFrame: 1 week after inclusion
measure: Microbiotic profile of total intestinal microbiota
timeFrame: 1 week after inclusion
measure: Food intake characteristics
timeFrame: 1 week after inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Tristan GABRIEL-SEGARD, Md
role: PRINCIPAL_INVESTIGATOR
References: