Last reviewed · How we verify
NCT02921243
Schizophrenia and the Gut Microbiome
trial in Schizophrenia in 11 participants. Completed in 18 June 2019.
18 June 2019
Quick facts
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 11 |
| Start date | 1 October 2016 |
| Primary completion | 18 June 2019 |
| Estimated completion | 18 June 2019 |
| Sites | 1 location across United States |
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
Sponsor
University of Maryland, Baltimore
Who can join
Adults 18 to 64, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02921243
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02921243 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
- Last refreshed: 19 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02921243.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing