Synbiotic Compound to Reduce Symptoms of Schizophrenia

NCT ID: NCT04226898

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2025-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Synbiotic Supplement

Intervention Type: BIOLOGICAL

Synbiotic supplement 1 powder stick by mouth daily

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.

Group Type: PLACEBO_COMPARATOR

Inert Compound

Intervention Type: BIOLOGICAL

Synbiotic supplement identical placebo 1 powder stick by mouth daily

Interventions

Synbiotic Supplement

Synbiotic supplement 1 powder stick by mouth daily

Intervention Type: BIOLOGICAL

Inert Compound

Synbiotic supplement identical placebo 1 powder stick by mouth daily

Intervention Type: BIOLOGICAL

Other Intervention Names

Probio-Tec® ABCG-Stick-25

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheppard Pratt Health System

OTHER

Sponsor Role: lead

Responsible Party

Faith Dickerson

Principal Investigator, Stanley Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faith Dickerson, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Sheppard Pratt Health System

Locations

Sheppard Pratt Health System

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily Katsafanas

Role: CONTACT

ekatsafanas@sheppardpratt.org

410-938-4360

Facility Contacts

Emily Katsafanas

Role: primary

ekatsafanas@sheppardpratt.org

443-608-3300

Other Identifiers

SMRI/SPHS: 2020-01

Identifier Type: -

Identifier Source: org_study_id