Anorexia Nervosa Clinical Trial
— INT-METAVOSAOfficial title:
Intestinal Metagenome of Undernourished in Patients
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | October 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients: 1. Anorexia nervosa as defined by DSM-5 (Diagnostic and Statistics Manual of Mental disorders 2. Undernutrition defined by BMI under 15 3. Age superior to 18 4. Patient hospitalised for undernutrition or seen in hospital day 5. Affiliation to the French social security regime or a similar regime 6. Patient signed informed consent Healthy volunteers: 1. Age superior to 18 2. Normal weight (BMI 18.5 - 25) 3. Affiliation to the French social security regime or a similar regime 4. Patient signed informed consent Exclusion Criteria: Patients: 1. Taking antibiotics two month before hospitalization 2. Purge line with laxative abuse one month before hospitalization 3. Another disease may be associated to microbiota profile modification (diabetes, MICI or digestive organ pathology, metabolic disease) 4. Obesity prior to anorexia nervosa 5. Safeguard justice procedure Healthy volunteers: 1. Metabolic anomaly 2. Recent weight change |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital Raymond Poincaré | Garches |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects. | 1 day | No | |
Secondary | Presence of a significant statistical association between this changes and metabolic troubles. | 1 day | No |
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