Food Intake and IgA Microbiota in Anorexia Nervosa (AAMIAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa; Healthy Volunteer
• Intervention / Treatment: Other: Stool sample; Other: Food intake evaluation

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tristan GABRIEL-SEGARD, Md; Phone Number: 33 04 77 12 02 61; Email: Tristan.Gabriel-Segard@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU Saint-etienne
    • Sub-Investigator: Bogdan GALUSCA, Md
    • Contact: Tristan GABRIEL-SEGARD, Md; Phone Number: 04 77 12 02 61; Email: Tristan.Gabriel-Segard@chu-st-etienne.fr
    • Principal Investigator: Natacha GERMAIN, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute anorexia nervosa; patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation.	Other: Stool sample; Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness; Other: Food intake evaluation; Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Experimental: Chronic anorexia nervosa; 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.	Other: Stool sample; Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness; Other: Food intake evaluation; Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Placebo Comparator: Healthy control; Healthy Patient will be included. They will have stool sample and Food intake evaluation.	Other: Stool sample; Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness; Other: Food intake evaluation; Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement; Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)
• Investigators: Principal Investigator: Tristan GABRIEL-SEGARD, Md, CHU Saint-etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: anorexia nervosa; microbiota; gut-brain-axis; immunology (IgA)
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 22CH356; 2023-A00318-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No