search
Back to results

Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS) (DIAMOnDS)

Primary Purpose

Anorexia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring microbiota, dysbiosis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women Over 15 years old and 3 months. Admitted in the specialized department for eating disorders of CHU Nantes for refeeding. With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type). Body Mass Index at admission below 16 kilogram per square meter. Written informed consent for patients over 18 years old/ oral informed consent from both the patient and a legal representative for patients under 18 years old. Affiliated with French social security system or beneficiary from such system. Exclusion Criteria: Pregnant and breastfeeding women. Who received a treatment with antibiotic/antifungal (other than local application) in the last three months. Who had a weight gain in the last month (5% or more of the patient's weight at admission). Under trusteeship or guardianship. Not fluent in French Who participate in another interventional study involving medication. Patients for whom stool collection or body mass composition analysis (with Dual-energy X-ray absorptiometry) couldn't be done during the first week of hospitalisation.

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anorexia nervosa

Arm Description

Outcomes

Primary Outcome Measures

Identification of gut microbiota biomarkers - composition
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Identification of gut microbiota biomarkers - diversity and richness
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype
Identification of gut microbiota biomarkers - metabolites
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.

Secondary Outcome Measures

Identification of the central adiposity phenotype
Proportion of patients who respond to the definition of the central adiposity phenotype during the refeeding. (The definition of the central adiposity phenotype will be characterised quantitatively through repeated measures of anthropometric data throughout the hospitalisation (waist-hip ratio (WHR), triceps skin fold, body mass index (BMI) and percentage from target weight) and qualitatively through Dual-energy X-ray Absorptiometry (DXA) imaging (repartition in body segment, relative proportion of lean and fat tissues, of subcutaneous and visceral fat mass, and of android and gynoid fat mass)).
Change from baseline in gut microbiota biomarkers - composition
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at discharge.
Change from baseline in gut microbiota biomarkers - diversity and richness
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at discharge.
Change from baseline in gut microbiota biomarkers - metabolites
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at discharge.

Full Information

First Posted
September 4, 2023
Last Updated
September 18, 2023
Sponsor
Nantes University Hospital
Collaborators
Fondation de France
search

1. Study Identification

Unique Protocol Identification Number
NCT06043154
Brief Title
Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
Acronym
DIAMOnDS
Official Title
Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Fondation de France

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
This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.
Detailed Description
Excessive concerns about body shape and intense fear of becoming fat are among the core features of anorexia nervosa. During refeeding, patients commonly report a disproportionate deposition of fat in the abdomen which could represent an obstacle for weight gain. It is not known whether these complaints are caused by dysmorphophobia or if the distribution of fat during refeeding could really not be uniform. Indeed, a "central adiposity phenotype" has already been objectified by anthropometric measures or imaging, with a higher proportion of visceral fat accumulated in the abdomen during the refeeding. This phenomenon could exacerbate body shape concerns and ultimately lead to an elevated risk of resistance to treatment and/or relapse. The present research project aims to explore the mechanisms that underlie these difficulties, especially by investigating the link between the gut microbiota (both composition and products) and the occurrence of the central adiposity phenotype, and the patients' fear to regain weight. Patients with severe to extreme anorexia nervosa admitted at hospital for refeeding will be included. . Stool and blood samples will be collected during the first week of admission and at discharge in order to investigate gut microbiota and metabolites. Anthromopetric data will be collected every week during hospitalisation. Dual-energy X-ray absorptiometry will be administrated at admission and discharge in order to investigate fat distribution and "central adiposity phenotype". This will allow to compare gut microbiota and metabolites between patients with and without occurence of the central adiposity phenotype during refeeding. (The definition of the central adiposity phenotype will be characterised quantitatively through repeated measures of anthropometric data throughout the hospitalisation (waist-hip ratio (WHR), triceps skin fold, body mass index (BMI) and percentage from target weight) and qualitatively through Dual-energy X-ray Absorptiometry (DXA) imaging (repartition in body segment, relative proportion of lean and fat tissues, of subcutaneous and visceral fat mass, and of android and gynoid fat mass)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
microbiota, dysbiosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorexia nervosa
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding
Other Intervention Name(s)
Clinical and biological measurements, blood and stool sample collection
Intervention Description
Clinical and biological measurements, blood and stool sample collection
Primary Outcome Measure Information:
Title
Identification of gut microbiota biomarkers - composition
Description
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Time Frame
At inclusion
Title
Identification of gut microbiota biomarkers - diversity and richness
Description
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype
Time Frame
At inclusion
Title
Identification of gut microbiota biomarkers - metabolites
Description
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Identification of the central adiposity phenotype
Description
Proportion of patients who respond to the definition of the central adiposity phenotype during the refeeding. (The definition of the central adiposity phenotype will be characterised quantitatively through repeated measures of anthropometric data throughout the hospitalisation (waist-hip ratio (WHR), triceps skin fold, body mass index (BMI) and percentage from target weight) and qualitatively through Dual-energy X-ray Absorptiometry (DXA) imaging (repartition in body segment, relative proportion of lean and fat tissues, of subcutaneous and visceral fat mass, and of android and gynoid fat mass)).
Time Frame
At inclusion
Title
Change from baseline in gut microbiota biomarkers - composition
Description
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at discharge.
Time Frame
At discharge, anticipated average 10 weeks
Title
Change from baseline in gut microbiota biomarkers - diversity and richness
Description
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at discharge.
Time Frame
At discharge, anticipated average 10 weeks
Title
Change from baseline in gut microbiota biomarkers - metabolites
Description
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at discharge.
Time Frame
At discharge, anticipated average 10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women only, due to the high influence of sex hormones and the low sex ratio of men admitted at hospital for anorexia nervosa.
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women Over 15 years old and 3 months. Admitted in the specialized department for eating disorders of CHU Nantes for refeeding. With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type). Body Mass Index at admission below 16 kilogram per square meter. Written informed consent for patients over 18 years old/ oral informed consent from both the patient and a legal representative for patients under 18 years old. Affiliated with French social security system or beneficiary from such system. Exclusion Criteria: Pregnant and breastfeeding women. Who received a treatment with antibiotic/antifungal (other than local application) in the last three months. Who had a weight gain in the last month (5% or more of the patient's weight at admission). Under trusteeship or guardianship. Not fluent in French Who participate in another interventional study involving medication. Patients for whom stool collection or body mass composition analysis (with Dual-energy X-ray absorptiometry) couldn't be done during the first week of hospitalisation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GRALL-BRONNEC, Professor
Phone
+33 2 40 84 76 20
Email
marie.bronnec@chu-nantes.fr
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie GRALL-BRONNEC, Professor
Phone
+33 2 40 84 76 20
Email
marie.bronnec@chu-nantes.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

Learn more about this trial

Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)

We'll reach out to this number within 24 hrs