Synbiotic Compound to Reduce Symptoms of Schizophrenia

NCT04226898 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SMRI/SPHS: 2020-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

Schizophrenia; Schizoaffective Disorder; Synbiotics; Synbiotic

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  14 weeks (week 0 to week 14)

• Intestinal Inflammation Markers (#1) Antibodies to Saccharomyces cerevisiae

  Screening, Week 8, Week 14

• Intestinal Inflammation Markers (#2) Antibodies to Gliadin

  Screening, Week 8, Week 14

• Intestinal Inflammation Markers (#3) Antibodies to Candida albicans

  Screening, Week 8, Week 14

• Intestinal Inflammation Markers (#4) C-reactive protein

  Screening, Week 8, Week 14

Study Arms (2)

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.

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.

Biological: Inert Compound

Interventions

Synbiotic Supplement BIOLOGICAL

Synbiotic supplement 1 powder stick by mouth daily

Also known as: Probio-Tec® ABCG-Stick-25

Synbiotic Supplement

Inert Compound BIOLOGICAL

Synbiotic supplement identical placebo 1 powder stick by mouth daily

Inert Compound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheppard Pratt Health System: lead

Study Sites (1)

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Faith Dickerson, PhD, MPH

  Sheppard Pratt Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Katsafanas

CONTACT

410-938-4360; ekatsafanas@sheppardpratt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Stanley Research Program

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 13, 2020
• Study Start: February 21, 2022
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)