Food Intake and IgA Microbiota in Anorexia Nervosa

NCT05842343 | Terminated

• 2 other identifiers: 22CH3562023-A00318-37
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Healthy Volunteer

Keywords

anorexia nervosa; microbiota; gut-brain-axis; immunology (IgA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ELISA assay of fecal immunoglobulins

  1 week after inclusion

• Microbiotic profile of total intestinal microbiota

  1 week after inclusion

• Food intake characteristics

  1 week after inclusion

Study Arms (3)

Acute anorexia nervosa

EXPERIMENTAL

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; Other: Food intake evaluation

Chronic anorexia nervosa

EXPERIMENTAL

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; Other: Food intake evaluation

Healthy control

PLACEBO COMPARATOR

Healthy Patient will be included. They will have stool sample and Food intake evaluation.

Other: Stool sample; Other: Food intake evaluation

Interventions

Stool sample OTHER

Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness

Acute anorexia nervosa; Chronic anorexia nervosa; Healthy control

Food intake evaluation OTHER

Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates

Acute anorexia nervosa; Chronic anorexia nervosa; Healthy control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patient does not understand French.
• laxative treatment in progress or stopped for less than 15 days,
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP): collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Tristan GABRIEL-SEGARD, Md

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: October 13, 2023
• Primary Completion: November 28, 2023
• Study Completion: February 2, 2024
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)