Food Intake and IgA Microbiota in Anorexia Nervosa

Healthy Volunteer Clinical Trial

— AAMIAM  

Official title:

Food Intake and IgA Microbiota in Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842343
• Other study ID #: 22CH356
• Secondary ID: 2023-A00318-37
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Tristan GABRIEL-SEGARD, Md
• Phone: 04 77 12 02 61
• Email: Tristan.Gabriel-Segard[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Healthy Volunteer

Intervention

Other:
• Stool sample
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
• Food intake evaluation
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total microbiotic profile	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.	1 week after inclusion
Secondary	ELISA assay of fecal immunoglobulins	ELISA determination of immunoglobulin A and immunoglobulin M in the stool of acute anorexia nervosa, chronic anorexia nervosa and control subjects.	1 week after inclusion
Secondary	Microbiotic profile of total intestinal microbiota	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.	1 week after inclusion
Secondary	Food intake characteristics	Qualitative and quantitative assessment of dietary intake by a dietary survey of acute anorexia nervosa, chronic anorexia nervosa and control subjects.	1 week after inclusion