Phase 2 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 65 years old (inclusive).
• People who are able to give written consent to participate.
• People who have been formally diagnosed with schizophrenia or schizoaffective disorder, confirmed using a structured diagnostic interview based on the DSM-5 (a standard mental health diagnostic guide).
• People who are living in the community (not currently admitted to hospital) at the time of enrolling.
• People whose psychotic symptoms are at least moderately severe, as measured by a specific symptom rating scale called the PANSS, with scores meeting certain thresholds at the screening visit (confirm with trial site).
• People who have been taking antipsychotic medication for at least 8 weeks before starting the study, with no changes to that medication in the 21 days before joining.
• People who are proficient in English.

Who may not be able to join:

• People who have a diagnosis of intellectual disability (under DSM-5 or an earlier version of the diagnostic guidelines).
• People who have a significant or unstable medical condition, such as congestive heart failure, liver disease, kidney failure, or cancer currently being treated.
• People with a primary immune system condition such as HIV, or who are currently receiving cancer chemotherapy, or who are taking systemic corticosteroids, methotrexate, or monoclonal antibodies for an autoimmune condition.
• People with a history of intravenous (IV) drug use.
• People who have had a moderate or severe substance use disorder (not including caffeine or tobacco) within the three months before the screening visit. A positive drug test at screening may lead to further review by the trial investigators to assess eligibility.
• People who have taken part in another clinical drug trial within the past 30 days.
• People who are pregnant or planning to become pregnant during the study period.
• People who have taken antibiotic medication within the 14 days before the second study visit. People in this situation may be rescreened at a later date once enough time has passed since antibiotic use.
• People who have been regularly taking probiotic or prebiotic supplements within the past 2 weeks. People in this situation may also be rescreened at a later date.
• People who have a documented diagnosis of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or coeliac disease.

Important: Always verify eligibility with the trial site directly before applying.