Synbiotic supplement to reduce schizophrenia symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial will enroll 68 outpatients and runs 14 weeks, including a 2-week placebo run-in followed by a 12-week randomized phase. Participants remain on stable antipsychotic medication and will be randomized to receive either the synbiotic product Probio-Tec ABCG-Stick-25 or an identical-appearing placebo. The synbiotic contains four probiotic strains (Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus) plus the prebiotic inulin. Intestinal inflammation markers (antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans, high-sensitivity CRP, and Pentraxin-3) and clinical symptom measures are collected to compare outcomes between groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Sheppard Pratt Health System
  Batlimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Faith Dickerson, PhD, MPH — Sheppard Pratt Health System
• Study coordinator: Emily Katsafanas
• Email: ekatsafanas@sheppardpratt.org
• Phone: 410-938-4360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.