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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT04486092
Eligibility Criteria:
Inclusion Criteria:
* Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists.
Exclusion Criteria:
* Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months
* Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study
* Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc.
* Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
* Had a surgical condition or a major physical illness
* Were pregnant or breast-feeding
* Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04486092
Study Brief:
Protocol Section:
NCT04486092