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:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT06593366
Eligibility Criteria:
Inclusion Criteria: All study subjects will have been diagnosed with AN (restricting type or binge eating/purging type) by the primary physician on the ED team, as per standard approach. Study participants will:
* Be 12-17 years-old at time of recruitment
* Have capacity to consent
* Be assigned female sex at birth (may be gender diverse)
* Be active patients in the pediatric ED program at MCH
* Have a weight that is \<85% of the Treatment Goal Weight, as determined by the treating physician
Exclusion Criteria: Potential study subjects will be excluded due to the following reasons:
* Exposure to antibiotics within two weeks of study randomization
* Initiation of new probiotics / oral nutritional supplements within two weeks of randomization
* Active pregnancy
* Active psychosis or suicidal ideation
* Other comorbidities that may affect weight or the gut microbiome including celiac disease, inflammatory bowel disease (or other conditions as determined by the study team)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT06593366
Study Brief:
Protocol Section:
NCT06593366