Recruiting
Phase 2

Synbiotic Compound

Sponsor:

Sheppard Pratt Health System

Code:

NCT04226898

Conditions

Schizophrenia

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Synbiotic Supplement

Inert Compound

Study Details

Brief 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.

Conditions

Schizophrenia

Schizoaffective Disorder

Study ID

NCT04226898

Start date

Feb 21, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Synbiotic Supplement

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.

placebo comparator: Inert Compound

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.

Interventions

Synbiotic Supplement

Synbiotic supplement 1 powder stick by mouth daily

Inert Compound

Synbiotic supplement identical placebo 1 powder stick by mouth daily

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) ]

Central Contacts and Locations

Central contacts

Emily Katsafanas

410-938-4360ekatsafanas@sheppardpratt.org

Locations

Sheppard Pratt Health System

Recruiting

Batlimore, Maryland, United States, 21285

Contacts

Emily Katsafanas

443-608-3300ekatsafanas@sheppardpratt.org

More Information

Sponsor

Sheppard Pratt Health System

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • Schizophrenia
  • Schizoaffective Disorder
  • Synbiotics
  • Synbiotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sheppard Pratt Health System on 2026-04-07.