At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 26 enrolled
Drug / intervention
Prebiotin +1 moredrug
Likely dose
Prebiotin 12gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prebiotic Treatment in People With Schizophrenia
In Brief
A Phase 4 clinical trial evaluating Prebiotin and Placebo for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 26 participants across 1 site.
Detailed Summary
The purpose of this study is to examine changes in serum butyrate levels with the prebiotic: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); the effect of OEI on the composition of the gastrointestinal microbiota in people with schizophrenia; and the relationship of the composition of the gut microbiota to various clinical, cognitive, and neuroimaging variables.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartJul 2019
Primary CompletionApr 2022
TodayJul 2026
First PostedAug 6, 2018
Enrollment StartJul 18, 2019
Primary CompletionApr 5, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.9 years ago
Interventions
Prebiotindrug
Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)
Placebodrug
placebo-OEI