NCT05527210 Prebiotic Treatment in People With Schizophrenia
| NCT ID | NCT05527210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-01-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder; 2. Age 18-60 years; 3. Considered clinically stable by the treating psychiatrist; 4. Currently treated with an antipsychotic, with no dose changes in last 14 days; 5. Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent; 6. BMI ≤ 40 Exclusion Criteria: 1. 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 2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes 3. Intellectual disability 4. Acute antibiotic use 5. Immune therapy within the last three months 6. Prebiotic or probiotic treatment within the last three months 7. Inability to understand English 8. Inability to cooperate with study procedures 9. Pregnant or lactation secondary to pregnancy 10. Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.
Contact & Investigator
Robert Buchanan, M.D.
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT05527210 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05527210 currently recruiting?
Yes, NCT05527210 is actively recruiting participants. Contact the research team at MGlassman@som.umaryland.edu for enrollment information.
Where is the NCT05527210 trial being conducted?
This trial is being conducted at Catonsville, United States.
Who is sponsoring the NCT05527210 clinical trial?
NCT05527210 is sponsored by University of Maryland, Baltimore. The principal investigator is Robert Buchanan, M.D. at University of Maryland, Baltimore. The trial plans to enroll 60 participants.
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