NCT05527210Active, not recruiting
Prebiotic Treatment in People With Schizophrenia
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Aug 2022
- Start date
- 25 Jan 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Schizophrenia
- NCT number
- NCT05527210
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 Jan 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immune therapy within the last three months
Other illness
- 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
Other
- Intellectual disability
- Acute antibiotic use
- Prebiotic or probiotic treatment within the last three months
- Inability to understand English
- Inability to cooperate with study procedures
- Pregnant or lactation secondary to pregnancy
- 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.
Who the study is looking for
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-60 years;
- Considered clinically stable by the treating psychiatrist;
- 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 ≤ 40
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maryland Psyciatric Research Center Coordinator of this site? Confirm its status | Catonsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.