Intestinal Metagenome of Undernourished in Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02920073

Acronym

INT-METAVOSA

Enrollment

250

Registered

2016-09-30

Start date

2016-10-31

Completion date

2018-10-31

Last updated

2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Undernourished

Keywords

Microbiota, anorexia nervosa, under nutrition, inpatients, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.	1 day

Secondary

Measure	Time frame
Presence of a significant statistical association between this changes and metabolic troubles.	1 day

Countries

France

Contacts

Primary ContactMouna Hanachi-Guidoum, MD

mouna.hanachi@aphp.fr+ 33 (1) 47 10 46 67

Backup ContactJean Claude Melchior, MD

jeanclaude.melchior@aphp.fr+ 33 (1) 71 14 49 44

Outcome results