RecruitingNot ApplicableNCT05527210
Prebiotic Treatment in People With Schizophrenia
Sponsor
University of Maryland, Baltimore
Enrollment
60 participants
Start Date
Jan 25, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria6
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 years;
- Considered clinically stable by the treating psychiatrist;
- Currently treated with an antipsychotic, with no dose changes in last 14 days;
- Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;
- BMI ≤ 40
Exclusion Criteria10
- Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- Intellectual disability
- Acute antibiotic use
- Immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
- Inability to understand English
- Inability to cooperate with study procedures
- Pregnant or lactation secondary to pregnancy
- Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.
Interventions
DIETARY_SUPPLEMENTPrebiotic
Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.
DIETARY_SUPPLEMENTPlacebo Prebiotic
Placebo prebiotic mixed into water
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05527210
Related Trials
Tolerability of MDMA in Schizophrenia
NCT057703751 location
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
NCT037940761 location
Cerebellar Stimulation and Cognitive Control
NCT032171101 location
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
NCT0688278555 locations
Cerebellar Modulation of Cognition in Psychosis
NCT061077642 locations