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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT06744751
Eligibility Criteria:
Inclusion Criteria:
* Female, aged 12-35 years, meets DSM-5 diagnostic criteria for anorexia nervosa.
* BMI \> 14 kg/m²; for children/adolescents, BMI \> the 0.3 percentile for their age.
* Presence of digestive symptoms (e.g., constipation, bloating, diarrhea).
* Duration of the disease (since the onset of dieting and weight loss) is less than two years.
* Each patient must understand the nature of this study and sign an informed consent form.
Exclusion Criteria:
* Co-morbid severe mental disorders such as schizophrenia, bipolar disorder, intellectual disability, persistent delusional disorder, schizoaffective disorder, or organic mental disorders.
* Substance abusers/addicts, individuals with a high suicide risk, or those with strong destructive impulses or antisocial behavior.
* Those with severe low body mass anorexia nervosa (e.g., blood pressure \< 80/50 mmHg, heart rate \< 40 beats/min, weight loss \> 1 kg per week, or those requiring assistance in sitting or squatting in a prone position).
* Patients with severe somatic diseases or comorbidities, including:
* Organic intestinal lesions such as congenital megacolon, intestinal obstruction, or intussusception.
* Previous pathological intestinal inflammatory conditions such as inflammatory bowel disease.
* History of traumatic brain injury, cerebral palsy, encephalitis, or other organic brain disorders.
* Severe hepatic or renal insufficiency (defined as levels greater than three times the upper limit of normal).
* Pregnant or breastfeeding women.
* Use of medications such as probiotics or antibiotics that clearly affect the intestinal flora within 1 months prior to the visit or during the treatment.
* Any other reason that the investigator deems unsuitable for participation in this clinical trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT06744751
Study Brief:
Protocol Section:
NCT06744751