UndernourishedINT-METAVOSANCT02920073
Intestinal Metagenome of Undernourished in Patients
An observational study of Undernourished and Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Undernourished, Anorexia Nervosa
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Undernourished inpatients with anorexia nervosa under enteral nutrition
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Healthy volunteers:
- Metabolic anomaly
- Recent weight change
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Raymond Poincaré
Garches, 92380
Mouna Hanachi-Guidoum, MD, + 33 (1) 47 10 46 67, mouna.hanachi@aphp.fr
Isavel Pimenta, + 33 (1) 47 10 46 67, isavel.pimenta@aphp.fr
About this study
The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.
Read the 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.
- Conditions
- Undernourished, Anorexia Nervosa
- Keywords
- Microbiota, anorexia nervosa, under nutrition, inpatients, enteral nutrition
- Medical subject headings
- Malnutrition, Anorexia Nervosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
Measured: 1 day
Secondary outcomes (1)
Presence of a significant statistical association between this changes and metabolic troubles.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernourishedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouna Hanachi-Guidoum, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920073
- Sponsor's protocol ID
- INT-METAVOSA
- Acronym
- INT-METAVOSA
- Status last verified
- Aug 2016
- First submitted
- 28 Sep 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Metagenome of Undernourished in Patients
- ClinicalTrials.gov ID
- NCT02920073
- Acronym / sponsor ID
- INT-METAVOSA / INT-METAVOSA
- Conditions
- Undernourished, Anorexia Nervosa
- Keywords
- Microbiota, anorexia nervosa, under nutrition, inpatients, enteral nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Undernourished inpatients with anorexia nervosa under enteral nutrition
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects.
Time frame: 1 day
1 secondary outcome
Presence of a significant statistical association between this changes and metabolic troubles.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mouna Hanachi-Guidoum, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernourished and Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mouna Hanachi-Guidoum, MD (+ 33 (1) 47 10 46 67, mouna.hanachi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of change of the gut microbiota in undernourished inpatients with anorexia nervosa compared to healthy subjects. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.