SchizophreniaPhase 2NCT04226898
Synbiotic Compound to Reduce Symptoms of Schizophrenia
A Phase 2 study testing Synbiotic Supplement and Inert Compound in people with Schizophrenia and Schizoaffective Disorder, run by Sheppard Pratt Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Synbiotic Supplement and Inert Compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to Dec 2027
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, inclusive.
- Capacity for written informed consent.
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
- Outpatient at the time of enrollment.
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.
- Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
- Proficient in the English language.
Who cannot join
- DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.
- A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.
- History of IV drug use.
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.
- Participated in any investigational drug trial in the past 30 days.
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- Pregnant or planning to become pregnant during the study period.
- Receipt of antibiotic medication within the 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met.
- Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.
- Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sheppard Pratt Health System
Batlimore, Maryland, 21285
Emily Katsafanas, 443-608-3300, ekatsafanas@sheppardpratt.org
About this study
Official title: A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation
The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
Read the detailed description
A total of n=68 participants with schizophrenia or schizoaffective disorder who have residual psychotic symptoms which are of at least moderate severity will be randomized. Intestinal inflammation will be assessed through the measurement of antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans as well as high-sensitivity C-Reactive protein and Pentraxin-3. The duration of the trial is 14 weeks: after a 2-week placebo run in, the participants will be randomized to receive the synbiotic compound or identical-appearing placebo over the 12 weeks of the randomized phase. The synbiotic compound is a quality-tested product, Probio-Tec ABCG-Stick-25, manufactured by ChrHansen which contains 4 strains of probiotic microorganisms - Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, and Lactobacillus rhamnosus - and the prebiotic, inulin, a fructan-containing polysaccharide which has been shown to increase the level of non-pathogenic bacteria in the gastrointestinal tract. All participants will also be maintained on a stable regimen of psychiatric medications prescribed by their treating psychiatrist.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Synbiotic Supplement, Inert Compound
- Keywords
- Schizophrenia, Schizoaffective Disorder, Synbiotics, Synbiotic
- 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.
Synbiotic SupplementBiological
Also called Probio-Tec® ABCG-Stick-25
Synbiotic supplement 1 powder stick by mouth daily
Inert CompoundBiological
Synbiotic supplement identical placebo 1 powder stick by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Supplement | Experimental | The active synbiotic supplement consists of a stick/packet containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick/sachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in. Receives: Biological: Synbiotic Supplement |
| Inert Compound | Placebo comparator | The inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in. Receives: Biological: Inert Compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Measured: 12 weeks (week 2 to week 14)
Secondary outcomes (6)
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score from the start of the placebo run-in to the end of the double-blind phase
Cognitive performance is measured by the MATRICS Consensus Cognitive Battery composite score in participants. MCCB is comprised of 10 tests: Trail Making Test Part A; Brief Assessment in Cognition in Schizophrenia Symbol Coding; Hopkins Verbal Learning Test-Revised; Wechsler Memory Scale-III Spatial Span; Letter Number Sequencing; Neuropsychological Assessment Battery Mazes; Brief Visuospatial Memory Test-Revised; Category Fluency Animal Naming; Mayer-Salovey-Caruso Emotional Intelligence Test Managing Emotions; and Continuous Performance Test-Identical Pairs. For each test, a score is derived based on the raw item values. Each of the individual item raw scores is standardized to age and gender corrected tscores which are then summed to convert into a composite score ranging from <214->486 based on the MCCB scoring manual, with a higher score reflecting better performance.
Measured: 14 weeks (week 0 to week 14)
Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to Saccharomyces cerevisiae. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Measured: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#2) Antibodies to Gliadin
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to gliadin. (All of the immuoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Measured: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#3) Antibodies to Candida albicans
Levels of intestinal inflammation will be assessed by the measurement of antibodies by immunoassays to Candida albicans. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Measured: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#4) C-reactive protein
Levels of intestinal inflammation will be assessed by the measurement of high-sensitivity C-reactive protein. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will b used.)
Measured: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#5) Pentraxin-3
Levels of intestinal inflammation will be assessed by the measurement of Pentraxin-3. (All of the immunoassays will be analyzed on the same scale. This is accomplished by standardizing the optical density values obtained from the immunoassays to those of a control population without a psychiatric disorder normalized to have a mean value of 1 and a standard deviation of 1. To adjust for multiple comparisons in the analysis of the 5 markers, the false discovery correction of Benjamani-Hochberg will be used.)
Measured: Screening, Week 8, Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start21 Feb 2022
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheppard Pratt Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faith Dickerson, Sheppard Pratt Health System
- Investigators
- Faith Dickerson, PhD, MPH, Principal investigator, Sheppard Pratt Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226898
- Sponsor's protocol ID
- SMRI/SPHS: 2020-01
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation
- ClinicalTrials.gov ID
- NCT04226898
- Acronym / sponsor ID
- SMRI/SPHS: 2020-01
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Synbiotics, Synbiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2020 (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 purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
Detailed description
A total of n=68 participants with schizophrenia or schizoaffective disorder who have residual psychotic symptoms which are of at least moderate severity will be randomized. Intestinal inflammation will be assessed through the measurement of antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans as well as high-sensitivity C-Reactive protein and Pentraxin-3. The duration of the trial is 14 weeks: after a 2-week placebo run in, the participants will be randomized to receive the synbiotic compound or identical-appearing placebo over the 12 weeks of the randomized phase. The synbiotic compound is a quality-tested product, Probio-Tec ABCG-Stick-25, manufactured by ChrHansen which contains 4 strains of probiotic microorganisms - Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, and Lactobacillus rhamnosus - and the prebiotic, inulin, a fructan-containing polysaccharide which has been shown to increase the level of non-pathogenic bacteria in the gastrointestinal tract. All participants will also be maintained on a stable regimen of psychiatric medications prescribed by their treating psychiatrist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Supplement | Experimental | Biological: Synbiotic SupplementThe active synbiotic supplement consists of a stick/packet containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick/sachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in. |
| Inert Compound | Placebo comparator | Biological: Inert CompoundThe inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65, inclusive.
- Capacity for written informed consent.
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
- Outpatient at the time of enrollment.
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.
Key exclusion criteria (10 listed)
- DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.
- A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.
- History of IV drug use.
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.
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 |
|---|---|---|
| Synbiotic SupplementAlso: Probio-Tec® ABCG-Stick-25Synbiotic supplement 1 powder stick by mouth daily | Biological | Synbiotic Supplement |
| Inert CompoundSynbiotic supplement identical placebo 1 powder stick by mouth daily | Biological | Inert Compound |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Time frame: 12 weeks (week 2 to week 14)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
6 secondary outcomes
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score from the start of the placebo run-in to the end of the double-blind phase
Time frame: 14 weeks (week 0 to week 14)
Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae
Time frame: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#2) Antibodies to Gliadin
Time frame: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#3) Antibodies to Candida albicans
Time frame: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#4) C-reactive protein
Time frame: Screening, Week 8, Week 14
Intestinal Inflammation Markers (#5) Pentraxin-3
Time frame: Screening, Week 8, Week 14
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 7 Apr 2026.
- Individual participant dataSharing planned: Yes. Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.
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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.
Faith Dickerson, PhD, MPH principal investigator
Sheppard Pratt Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synbiotic Supplement and Inert Compound in people with Schizophrenia and Schizoaffective Disorder, run by Sheppard Pratt Health System 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 7 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: looking for participants now, as of the sponsor's last update on 7 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Emily Katsafanas (410-938-4360, ekatsafanas@sheppardpratt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (time frame: 12 weeks (week 2 to week 14)). 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 7 Apr 2026.