Intestinal Metagenome of Undernourished in Patients
INT-METAVOSA
1 other identifier
observational
250
1 country
1
Brief Summary
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedDecember 13, 2016
August 1, 2016
1 year
September 28, 2016
December 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
1 day
Secondary Outcomes (1)
Presence of a significant statistical association between this changes and metabolic troubles.
1 day
Eligibility Criteria
Undernourished inpatients with anorexia nervosa under enteral nutrition
You may qualify if:
- Patients:
- Anorexia nervosa as defined by DSM-5 (Diagnostic and Statistics Manual of Mental disorders
- Undernutrition defined by BMI under 15
- Age superior to 18
- Patient hospitalised for undernutrition or seen in hospital day
- Affiliation to the French social security regime or a similar regime
- Patient signed informed consent
- Healthy volunteers:
- Age superior to 18
- Normal weight (BMI 18.5 - 25)
- Affiliation to the French social security regime or a similar regime
- Patient signed informed consent
You may not qualify if:
- Patients:
- Taking antibiotics two month before hospitalization
- Purge line with laxative abuse one month before hospitalization
- Another disease may be associated to microbiota profile modification (diabetes, MICI or digestive organ pathology, metabolic disease)
- Obesity prior to anorexia nervosa
- Safeguard justice procedure
- Healthy volunteers:
- Metabolic anomaly
- Recent weight change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Raymond Poincaré
Garches, 92380, France
Biospecimen
Stool Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mouna Hanachi-Guidoum, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2016
First Posted
September 30, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
December 13, 2016
Record last verified: 2016-08