Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa (ANOSTOOL)

July 28, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne
Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

  • anorexia nervosa with and without hunger
  • constitutional leanness
  • control subjects

Description

Inclusion criteria common to all four groups

  • Patient affiliated or entitled to a social security scheme
  • Patient who received informed information about the study
  • Patient does not object to participating in the study

Inclusion criteria specific to mental anorexia

  • BMI between 13 and 17.5 kg/m2
  • Diagnostic and Statistical Manual of Mental Disorders IV restrictive anorexia nervosa diagnostic criteria
  • Evolution of the troubles since less than 1 year.
  • with feeling of hunger: "hunger" = total score on the 24-hour hunger scale > 15 and presence of the three prandial peaks (score = 3)
  • having lost the feeling of hunger: "not hungry" = total score on the 24-hour hunger scale ≤ 5 and absence of the three prandial peaks (score ≤ 2)

Inclusion criteria specific to constitutionally thin patients

  • BMI between 13 and 17.5 kg/m2
  • Stable weight for at least 3 months
  • No eating disorder
  • No markers of undernutrition

Inclusion criteria specific to normal weight subjects

  • 20 kg/m2 ≤ BMI ≤ 25 kg/m2
  • Stable weight for at least 3 months
  • No eating disorder
  • No markers of undernutrition

Non-inclusion criteria for all subjects :

  • Antibiotic treatment during the 2 months preceding the sampling.
  • History of immune system/autoimmune disease: Immune deficiency, Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, psoriasis, Behçet's disease, celiac disease, type I diabetes.
  • History of metabolic pathology: intestinal malabsorptive disease
  • Medical or surgical history deemed by the investigator to be incompatible with this study.
  • Severe progressive condition other
  • Pregnant woman
  • Majors under guardianship or subjects deprived of their liberty by judicial or administrative decision
  • Ongoing psychotropic treatment
  • Progressive diarrhea (Bristol Type V and VI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
restrictive anorexia nervosa with hunger
Biological: blood sampling
12 ml sample
Other: stool sampling
20 g sample
Other: urine sampling
18 ml sample
Diagnostic test: neuropsychological tests
  • Go-nogo
  • flexibility
  • food stroop
  • implicit and explicit evaluation
  • Child Depression Inventory
  • Hamilton Depression Rating Scale
restrictive anorexia nervosa without hunger
Biological: blood sampling
12 ml sample
Other: stool sampling
20 g sample
Other: urine sampling
18 ml sample
Diagnostic test: neuropsychological tests
  • Go-nogo
  • flexibility
  • food stroop
  • implicit and explicit evaluation
  • Child Depression Inventory
  • Hamilton Depression Rating Scale
constitutional thinness
Biological: blood sampling
12 ml sample
Other: stool sampling
20 g sample
Other: urine sampling
18 ml sample
Diagnostic test: neuropsychological tests
  • Go-nogo
  • flexibility
  • food stroop
  • implicit and explicit evaluation
  • Child Depression Inventory
  • Hamilton Depression Rating Scale
control subjects without eating disorders
Biological: blood sampling
12 ml sample
Other: stool sampling
20 g sample
Other: urine sampling
18 ml sample
Diagnostic test: neuropsychological tests
  • Go-nogo
  • flexibility
  • food stroop
  • implicit and explicit evaluation
  • Child Depression Inventory
  • Hamilton Depression Rating Scale

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
determination of bacterial microbiological profile by 16s sequencing of stool samples
Time Frame: at inclusion
at inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of the metabolomic profile
Time Frame: at inclusion
evaluated by mass spectrometry (MS/MS) of urine
at inclusion
Neurocognitive evaluation
Time Frame: at 2 months
evaluated with questionnaire go-nogo
at 2 months
Neurocognitive evaluation
Time Frame: at 2 months
evaluated with questionnaire of flexibility
at 2 months
Neurocognitive evaluation
Time Frame: at 2 months
evaluated with questionnaire : food troop
at 2 months
Neurocognitive evaluation
Time Frame: at 2 months
evaluated with questionnaires : implicit and explicit evaluation.
at 2 months
Psychometric scaling for thymic evaluation
Time Frame: at 2 months
evaluated with questionnaire : Child Depression Inventory
at 2 months
Psychometric scaling for thymic evaluation
Time Frame: at 2 months
evaluated with questionnaire : Hamilton Depression Rating Scale
at 2 months
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time Frame: at inclusion
Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin
at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time Frame: at inclusion
immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein
at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time Frame: at inclusion
circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4.
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natacha GERMAIN, CHU de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18CH109
  • 2018-A01731-54 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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