Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02170467
Eligibility Criteria:
Inclusion Criteria:
Patients with anorexia nervosa :
* female,
* living in Upper Normandy since 1 year at least,
* between 18 and 50 years of age
* with a BMI between 14 and 16 kg/m²,
* diagnosed as anorexia nervosa according to the DSM IV criteria
* hospitalised for the first time in the Nutrition Unit
* not being pregnant (effective contraception and negative pregnancy test)
* not breast-feeding,
* HIV-1 negative ,
* HIV-2 negative,
* HBV negative (hépatitis B virus),
* HCV negative (hépatitis C virus),
* Affiliated to the National Health Service,
* Giving a filled informed consent,
* Not included in other studies
Controls :
* female,
* living in Upper Normandy since 1 year at least,
* between 18 and 50 years of age,
* with a BMI between 20 and 24,9 kg/m²,
* without antecedent or current diagnosis of eating disorders (DSM IV criteria),
* without dyspepsia or irritable bowel syndrom for 6 month,
* not being pregnant (effective contraception and negative pregnancy test)
* not breast-feeding,
* HIV-1 negative ,
* HIV-2 negative,
* HBV negative (hépatitis B virus),
* HCV negative (hépatitis C virus),
* Affiliated to the National Health Service,
* Giving a filled informed consent,
* Not included in other studies
Exclusion Criteria:
Patients with anorexia nervosa :
* Adult under guardianship,
* Patient with inflammatory bowel disease and/or psychotic disorders,
* Antecedent of digestive surgery,
* Drug addiction for the last 6 month,
* Alcohol and/or other substance use disorder,
* Current immunological treatment, and/or non steroidal anti inflamatory and/or corticosteroids and/or anticoagulants and/or platelet antiaggregants
* galactosemia
* Lactulose intolerance,
* Laxatives intake in the last 3 days
* Antecedent of digestive surgery,
Controls :
* Adult under guardianship,
* Patient with inflammatory bowel disease and/or psychotic disorders,
* Antecedent of digestive surgery,
* Drug addiction for the last 6 month,
* Alcohol and/or other substance use disorder,
* Current immunological treatment, and/or non steroidal anti inflamatory and/or corticosteroids and/or anticoagulants and/or platelet antiaggregants
* galactosemia
* Lactulose intolerance,
* Laxatives intake in the last 3 days
* Antecedent of digestive surgery,
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02170467
Study Brief:
Protocol Section:
NCT02170467