Intestinal Metagenome of Undernourished in Patients

Anorexia Nervosa Clinical Trial

— INT-METAVOSA  

Official title:

Intestinal Metagenome of Undernourished in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02920073
• Other study ID #: INT-METAVOSA
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2016
• Last updated: December 12, 2016
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mouna Hanachi-Guidoum, MD
• Phone: + 33 (1) 47 10 46 67
• Email: mouna.hanachi[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Malnutrition
• Undernourished

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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