Health TrialsbyHealthPanel

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

ConditionsAnorexia NervosaDysbiosisAnxious Depression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged ≥18 years;

Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);

Body mass index (BMI) (P/T2) < 15;

Hospitalization for nutrition rehabilitation;

Disqualifiers

Patients no-responding all criteria of DSM-5 or CIDI scores;

Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization;

Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);

Patients under guardianship;

Trial population

Hospitalized patients with anorexia nervosa for nutrition rehabilitation in the department of nutrition in Paul Brousse hospital (Villejuif) - APHP.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Stool and blood samples

    Biological/Vaccine

    Stool and blood samples

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Anorexia patients1 intervention
Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

Eating Disorder

By Eating Disorder Inventory (EDI-3)

Time frame
at baseline
2

Anxio-depressive symptomatologic assessements by HAD score

By HAD score

Time frame
at baseline
3

Anxio-depressive symptomatologic assessements by scale of Beck BDI 13

By scale of Beck BDI 13

Time frame
at baseline
4

Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale

By LSAS Lieboweitz social anxiety scale

Time frame
at baseline

Secondary outcomes

1

Diversity indice

By index de Sympson et Shannon

Time frame
at baseline
2

Intestinal permeability

By serum zonulin level

Time frame
at baseline
3

Immunity alteration

By interleukins and CRP level

Time frame
at baseline
4

Liver function

Cytolyse analysis in serum

Time frame
at baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Fondation de France

Collaborator

Source ClinicalTrials.gov
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