Anorexia NervosaANOSTOOLNCT03736642
Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa
An observational study of Anorexia Nervosa and Eating Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Eating Disorder
- What is being tested?
- blood sampling, stool sampling and urine sampling
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * anorexia nervosa with and without hunger * constitutional leanness * control subjects
Who may be able to join
- 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
- 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.
Show all 27Show fewer
- 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
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anorexia Nervosa, Eating Disorder
- Being tested
- blood sampling, stool sampling, urine sampling, neuropsychological tests
- Keywords
- stool, constitutional thinness
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
12 ml sample
stool samplingOther
20 g sample
urine samplingOther
18 ml sample
neuropsychological testsDiagnostic test
- Go-nogo
- flexibility
- food stroop
- implicit and explicit evaluation
- Child Depression Inventory
- Hamilton Depression Rating Scale
| Study group | Role | What they receive |
|---|---|---|
| restrictive anorexia nervosa with hunger | Not described Receives: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests | |
| restrictive anorexia nervosa without hunger | Not described Receives: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests | |
| constitutional thinness | Not described Receives: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests | |
| control subjects without eating disorders | Not described Receives: Biological: blood sampling; Other: stool sampling; Other: urine sampling; Diagnostic Test: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of bacterial microbiological profile by 16s sequencing of stool samples
Measured: at inclusion
Secondary outcomes (10)
Determination of the metabolomic profile
evaluated by mass spectrometry (MS/MS) of urine
Measured: at inclusion
Neurocognitive evaluation
evaluated with questionnaire go-nogo
Measured: at 2 months
Neurocognitive evaluation
evaluated with questionnaire of flexibility
Measured: at 2 months
Neurocognitive evaluation
evaluated with questionnaire : food troop
Measured: at 2 months
Neurocognitive evaluation
evaluated with questionnaires : implicit and explicit evaluation.
Measured: at 2 months
Psychometric scaling for thymic evaluation
evaluated with questionnaire : Child Depression Inventory
Measured: at 2 months
Psychometric scaling for thymic evaluation
evaluated with questionnaire : Hamilton Depression Rating Scale
Measured: at 2 months
Determination of the plasma profile of intestinal physiology markers and immunological markers
Intestinal permeability markers: ASCA, antiglycan, anti GP2 IgG/IgA, calprotectin
Measured: at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
immunoglobulin repertoire: A and M, inflammatory molecules: C-reactive protein
Measured: at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
circulating interleukins of the Th17 profile: IL17, IL23, IL6, IL1β, IL 22, IL21, IL33, IL31, TNFα, IFNγ, IL9, IL10, IL4.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 May 2019
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natacha GERMAIN, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736642
- Sponsor's protocol ID
- 18CH109
- Other IDs
- 2018-A01731-54
- Acronym
- ANOSTOOL
- Status last verified
- Jul 2020
- First submitted
- 2 Nov 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03736642
- Acronym / sponsor ID
- ANOSTOOL / 18CH109
- Conditions
- Anorexia Nervosa, Eating Disorder
- Keywords
- stool, constitutional thinness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| restrictive anorexia nervosa with hunger | – | Biological: blood sampling, Other: stool sampling, Other: urine sampling, Diagnostic Test: neuropsychological tests |
| restrictive anorexia nervosa without hunger | – | Biological: blood sampling, Other: stool sampling, Other: urine sampling, Diagnostic Test: neuropsychological tests |
| constitutional thinness | – | Biological: blood sampling, Other: stool sampling, Other: urine sampling, Diagnostic Test: neuropsychological tests |
| control subjects without eating disorders | – | Biological: blood sampling, Other: stool sampling, Other: urine sampling, Diagnostic Test: neuropsychological tests |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * anorexia nervosa with and without hunger * constitutional leanness * control subjects
Key inclusion criteria (27 listed)
- 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
- BMI between 13 and 17.5 kg/m2
- Diagnostic and Statistical Manual of Mental Disorders IV restrictive anorexia nervosa diagnostic criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling12 ml sample | Biological | constitutional thinness, control subjects without eating disorders, restrictive anorexia nervosa with hunger, restrictive anorexia nervosa without hunger |
| stool sampling20 g sample | Other | constitutional thinness, control subjects without eating disorders, restrictive anorexia nervosa with hunger, restrictive anorexia nervosa without hunger |
| urine sampling18 ml sample | Other | constitutional thinness, control subjects without eating disorders, restrictive anorexia nervosa with hunger, restrictive anorexia nervosa without hunger |
| neuropsychological tests* Go-nogo * flexibility * food stroop * implicit and explicit evaluation * Child Depression Inventory * Hamilton Depression Rating Scale | Diagnostic test | constitutional thinness, control subjects without eating disorders, restrictive anorexia nervosa with hunger, restrictive anorexia nervosa without hunger |
Primary outcome
determination of bacterial microbiological profile by 16s sequencing of stool samples
Time frame: at inclusion
10 secondary outcomes
Determination of the metabolomic profile
Time frame: at inclusion
Neurocognitive evaluation
Time frame: at 2 months
Neurocognitive evaluation
Time frame: at 2 months
Neurocognitive evaluation
Time frame: at 2 months
Neurocognitive evaluation
Time frame: at 2 months
Psychometric scaling for thymic evaluation
Time frame: at 2 months
Psychometric scaling for thymic evaluation
Time frame: at 2 months
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time frame: at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time frame: at inclusion
Determination of the plasma profile of intestinal physiology markers and immunological markers
Time frame: at inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natacha GERMAIN principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Eating Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of bacterial microbiological profile by 16s sequencing of stool samples (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.