Phase 4
Completed N=22
Prebiotic Treatment in People With Schizophrenia - Pilot Study
Source: ClinicalTrials.gov NCT03617783 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Change in Serum Butyrate Levels — 2.42; 2.34; 2.88; 2.40 mg/ml
◆ Published Evidence
Emerging
9citations · ~5 / year
Prebiotic Treatment in People With Schizophrenia.
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.
Linked Publications
-
Prebiotic Treatment in People With Schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Butyrate Levels |
2.42; 2.34; 2.88; 2.40 | — |
Eligibility Criteria
Inclusion Criteria
- DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 years
- Clinically stable as determined by opinion of treating clinician
- Currently treated with an antipsychotic, with no dose changes in last 14 days
- Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent.
- BMI ≤ 35
Exclusion Criteria
- 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
- Antibiotic or immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
- Inability to understand English
- Inability to cooperate with study procedures
- Pregnant or lactating women secondary to pregnancy
- Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use Disorder) within last 3 months
Data sourced from ClinicalTrials.gov (NCT03617783) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.