Intestinal Metagenome of Undernourished in Patients (INT-METAVOSA)

December 12, 2016 updated by: Assistance Publique - Hôpitaux de Paris
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Garches, France, 92380
        • Recruiting
        • Hôpital Raymond Poincaré
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Undernourished inpatients with anorexia nervosa under enteral nutrition

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Mouna Hanachi-Guidoum, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-METAVOSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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