Food Intake and IgA Microbiota in Anorexia Nervosa

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa; Healthy Volunteer
• Interventions: Other: Stool sample; Other: Food intake evaluation

• Registration Number: NCT05842343
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-10-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute anorexia nervosa	Stool sample	patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation.
Chronic anorexia nervosa	Stool sample	Patient diagnose for anorexia nervosa at least 5 years ago and still maintaining a significant thinness will be included. They will have stool sample and Food intake evaluation.
Healthy control	Stool sample	Healthy Patient will be included. They will have stool sample and Food intake evaluation.
Chronic anorexia nervosa	Food intake evaluation	Patient diagnose for anorexia nervosa at least 5 years ago and still maintaining a significant thinness will be included. They will have stool sample and Food intake evaluation.
Acute anorexia nervosa	Food intake evaluation	patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation.
Healthy control	Food intake evaluation	Healthy Patient will be included. They will have stool sample and Food intake evaluation.

Primary Outcome Measures

Name	Time	Method
Total microbiotic profile	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 Outcome Measures

Name	Time	Method
Food intake characteristics	1 week after inclusion	Qualitative and quantitative assessment of dietary intake by a dietary survey of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
ELISA assay of fecal immunoglobulins	1 week after inclusion	ELISA determination of immunoglobulin A and immunoglobulin M in the stool of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Microbiotic profile of total intestinal microbiota	1 week after inclusion	Total microbiotic profile (abundance and diversity) of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France