NCT04226898

Synbiotic Compound to Reduce Symptoms of Schizophrenia

A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sheppard Pratt Health System · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Synbiotic Supplement	Synbiotic supplement 1 powder stick by mouth daily
BIOLOGICAL	Inert Compound	Synbiotic supplement identical placebo 1 powder stick by mouth daily

Timeline

• Start date: 2022-02-21
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2020-01-13
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study