Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05527210
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-08-30
Brief Title:
Prebiotic Treatment in People With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Prebiotic Treatment in People With Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCIS
Brief 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
Detailed Description:
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 andor 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 andor 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 andor changes in gut microbiota composition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61AT009990 | NIH | None | httpsreporternihgovquickSearchR61AT009990 |