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Clinical Trials/NCT05842343
NCT05842343
Terminated
Not Applicable

Food Intake and IgA Microbiota in Anorexia Nervosa

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country14 target enrollmentOctober 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
14
Locations
1
Primary Endpoint
Total microbiotic profile
Status
Terminated
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2023
End Date
February 2, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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.

Outcomes

Primary Outcomes

Total microbiotic profile

Time Frame: 1 week after inclusion

abundance and diversity parameters of the IgA microbiota fraction of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.

Secondary Outcomes

  • Food intake characteristics(1 week after inclusion)
  • ELISA assay of fecal immunoglobulins(1 week after inclusion)
  • Microbiotic profile of total intestinal microbiota(1 week after inclusion)

Study Sites (1)

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