search
Back to results

Food Intake and IgA Microbiota in Anorexia Nervosa (AAMIAM)

Primary Purpose

Anorexia Nervosa, Healthy Volunteer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stool sample
Food intake evaluation
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring anorexia nervosa, microbiota, gut-brain-axis, immunology (IgA)

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 13 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes. For the chronic subgroup: BMI between 13 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.

Sites / Locations

  • Chu Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Acute anorexia nervosa

Chronic anorexia nervosa

Healthy control

Arm Description

patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Food intake characteristics
Qualitative and quantitative assessment of dietary intake by a dietary survey of acute anorexia nervosa, chronic anorexia nervosa and control subjects.

Full Information

First Posted
April 24, 2023
Last Updated
October 13, 2023
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)
search

1. Study Identification

Unique Protocol Identification Number
NCT05842343
Brief Title
Food Intake and IgA Microbiota in Anorexia Nervosa
Acronym
AAMIAM
Official Title
Food Intake and IgA Microbiota in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Healthy Volunteer
Keywords
anorexia nervosa, microbiota, gut-brain-axis, immunology (IgA)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute anorexia nervosa
Arm Type
Experimental
Arm Description
patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation.
Arm Title
Chronic anorexia nervosa
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy control
Arm Type
Placebo Comparator
Arm Description
Healthy Patient will be included. They will have stool sample and Food intake evaluation.
Intervention Type
Other
Intervention Name(s)
Stool sample
Intervention Description
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Intervention Type
Other
Intervention Name(s)
Food intake evaluation
Intervention Description
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Primary Outcome Measure Information:
Title
Total microbiotic profile
Description
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.
Time Frame
1 week after inclusion
Secondary Outcome Measure Information:
Title
ELISA assay of fecal immunoglobulins
Description
ELISA determination of immunoglobulin A and immunoglobulin M in the stool of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Time Frame
1 week after inclusion
Title
Microbiotic profile of total intestinal microbiota
Description
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.
Time Frame
1 week after inclusion
Title
Food intake characteristics
Description
Qualitative and quantitative assessment of dietary intake by a dietary survey of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Time Frame
1 week after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 13 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes. For the chronic subgroup: BMI between 13 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tristan GABRIEL-SEGARD, Md
Phone
04 77 12 02 61
Ext
33
Email
Tristan.Gabriel-Segard@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristan GABRIEL-SEGARD, Md
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tristan GABRIEL-SEGARD, Md
Phone
04 77 12 02 61
Email
Tristan.Gabriel-Segard@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Bogdan GALUSCA, Md
First Name & Middle Initial & Last Name & Degree
Natacha GERMAIN, Md

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Food Intake and IgA Microbiota in Anorexia Nervosa

We'll reach out to this number within 24 hrs