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NCT03617783 · ClinicalTrials.gov registry record · Phase 4
Prebiotic Treatment in People With Schizophrenia - Pilot Study
A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03617783: Completed Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore.
NCT03617783 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 26 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617783, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We will use the following procedure to assess the effect of Prebiotin (OEI) on serum butyrate levels: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) Day 11, following the 10 day course of OEI/placebo treatment. We will use OEI for the inulin challenge. On the night prior to each test day, participants will receive a digestable and non-fermentable meal, e.g. lasagna. They will then fast from midnight until the morning, when they will receive the
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prebiotin
Study Locations (1)
Maryland
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) - Catonsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2022-04-05 |
| Phase | Phase 4 |
What the finished NCT03617783 record still lists
NCT03617783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03617783 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03617783 about?
NCT03617783 is a clinical study titled "Prebiotic Treatment in People With Schizophrenia - Pilot Study". 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 t...
What is the current status of trial NCT03617783?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2019-07-18. Estimated completion is 2022-04-05.
What conditions does trial NCT03617783 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT03617783?
The interventions under investigation include: Placebo (DRUG), Prebiotin (DRUG).
Who is sponsoring clinical trial NCT03617783?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03617783 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03617783's enrollment target sits among peer trials
26 270th of 315 higher than 45 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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