Synbiotic Compound to Reduce Symptoms of Schizophrenia

Status Recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04226898
Study type	Interventional
Source	Sheppard Pratt Health System
Contact	Emily Katsafanas
Phone	410-938-4360
Email	ekatsafanas@sheppardpratt.org
Status	Recruiting
Phase	Phase 2
Start date	February 21, 2022
Completion date	January 2025

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