Maryland Psyciatric Research Center
Catonsville, Maryland, 21228, United States
NCT Number: NCT05527210
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.
This study is active but is not currently recruiting participants.
18 year–60 year
All sexes
Interventional
Not applicable
Catonsville, Maryland, 21228, United States
The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.
Other names: Prebiotin®
Placebo prebiotic mixed into water
Other names: maltodextrin
Time frame: 12 weeks
Number of participants with an increase in serum butyrate levels at 12 weeks.
Time frame: 12 weeks
Number of participants with an increase in MCCB composite score at 12 weeks.
Time frame: 12 weeks
Number of participants with an increased incidence of side effects at 12 weeks.
Time frame: 12 weeks
Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS).
Time frame: 12 weeks
Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS).
Time frame: 12 weeks
Number of participants with an increase in negative symptoms at 12 weeks, measured by the • Scale for the Assessment of Negative Symptoms (SANS).
Time frame: 12 weeks
Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks.
Time frame: 12 weeks
Number of participants with an increase in cytokine, gut permeability, or gut microbiota composition levels at 12 weeks.
University of Maryland, Baltimore
Other
Acronym: FOCIS
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