SchizophreniaFOCISNCT05527210
Prebiotic Treatment in People With Schizophrenia
A study testing Prebiotic in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Acute antibiotic use
- Immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psyciatric Research Center
Catonsville, Maryland, 21228
About this study
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.
Read the detailed description
The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Prebiotic, Placebo Prebiotic
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Also called Prebiotin®
Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.
Placebo PrebioticDietary supplement
Also called maltodextrin
Placebo prebiotic mixed into water
| Study group | Role | What they receive |
|---|---|---|
| Active Study Med | Active comparator | Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks. Receives: Dietary Supplement: Prebiotic |
| Placebo | Placebo comparator | Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks. Receives: Dietary Supplement: Placebo Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum butyrate levels
Number of participants with an increase in serum butyrate levels at 12 weeks.
Measured: 12 weeks
Cognition
Number of participants with an increase in MCCB composite score at 12 weeks.
Measured: 12 weeks
Incidence of Side Effects
Number of participants with an increased incidence of side effects at 12 weeks.
Measured: 12 weeks
Secondary outcomes (5)
Change in Affective Symptoms
Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS).
Measured: 12 weeks
Change in Positive Symptoms
Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS).
Measured: 12 weeks
Change in Negative Symptoms
Number of participants with an increase in negative symptoms at 12 weeks, measured by the • Scale for the Assessment of Negative Symptoms (SANS).
Measured: 12 weeks
Changes in Serum Measurements
Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks.
Measured: 12 weeks
Effects of Gut Composition
Number of participants with an increase in cytokine, gut permeability, or gut microbiota composition levels at 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start25 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Deanna Kelly, University of Maryland, Baltimore
- Investigators
- Robert Buchanan, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527210
- Sponsor's protocol ID
- HP-00102648
- Other IDs
- R61AT009990
- Acronym
- FOCIS
- Status last verified
- Jul 2026
- First submitted
- 30 Aug 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Treatment in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT05527210
- Acronym / sponsor ID
- FOCIS / HP-00102648
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Study Med | Active comparator | Dietary Supplement: PrebioticParticipants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo PrebioticParticipants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
- Acute antibiotic use
- Immune therapy within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticAlso: Prebiotin®Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste. | Dietary supplement | Active Study Med |
| Placebo PrebioticAlso: maltodextrinPlacebo prebiotic mixed into water | Dietary supplement | Placebo |
Primary outcome
Change in serum butyrate levels
Time frame: 12 weeks
Number of participants with an increase in serum butyrate levels at 12 weeks.
Cognition
Time frame: 12 weeks
Number of participants with an increase in MCCB composite score at 12 weeks.
Incidence of Side Effects
Time frame: 12 weeks
Number of participants with an increased incidence of side effects at 12 weeks.
5 secondary outcomes
Change in Affective Symptoms
Time frame: 12 weeks
Change in Positive Symptoms
Time frame: 12 weeks
Change in Negative Symptoms
Time frame: 12 weeks
Changes in Serum Measurements
Time frame: 12 weeks
Effects of Gut Composition
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Buchanan, M.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum butyrate levels (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.