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Intestinal Metagenome of Undernourished in Patients

NCT ID: NCT02920073

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Undernourished Anorexia Nervosa

Keywords

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Microbiota anorexia nervosa under nutrition inpatients enteral nutrition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mouna Hanachi-Guidoum, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Raymond Poincaré

Garches, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mouna Hanachi-Guidoum, MD

Role: CONTACT

Phone: + 33 (1) 47 10 46 67

Email: [email protected]

Jean Claude Melchior, MD

Role: CONTACT

Phone: + 33 (1) 71 14 49 44

Email: [email protected]

Facility Contacts

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Mouna Hanachi-Guidoum, MD

Role: primary

Isavel Pimenta

Role: backup

Other Identifiers

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INT-METAVOSA

Identifier Type: -

Identifier Source: org_study_id