Clinical trial NCT02920073: Intestinal Metagenome of Undernourished in Patients
Official title: Intestinal Metagenome of Undernourished in Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Undernourished
Anorexia Nervosa
Keywords: Microbiota
anorexia nervosa
under nutrition
inpatients
enteral nutrition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undernourished inpatients with anorexia nervosa under enteral nutrition

Brief summary: The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.

Detailed description: This is a prospective, comparative, non-interventional study involving one clinical nutrition unit in France. Gut microbial will be evaluated with feces between patients and healthy volunteers.

Main investigations:

* Presence of gut microbial deviation compared to healthy volunteers;
* Presence of a significant statistical association between this deviation and metabolic disorders.

For each patient under the routine care a clinical examination and a blood sample will be done for standard biology report and nutrition. The age, gender, weight, height (for calculation of BMI), type of anorexia nervosa will be also collected with the pathological behavior associated (physical and intellectual hyperactivity, potomania, ongoing supplements drug taking including vitamins and trace elements). Eating and psychological disorders will be evaluated with EDI (eating disorder inventory) questionnaire.

Only the age, gender, height, weight (BMI), medical antecedents and ongoing treatment taking will be collected.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
timeFrame: 1 day
Secondary outcomes:
measure: Presence of a significant statistical association between this changes and metabolic troubles.
timeFrame: 1 day
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Mouna Hanachi-Guidoum, MD
role: PRINCIPAL_INVESTIGATOR
References: