Prebiotic Treatment in People With Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Maryland, Baltimore
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prebiotic
- Placebo Prebiotic
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Maryland, Baltimore
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov