The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella pneumoniae without adverse effects.
Species within the genus Bifidobacterium are vital components of the human microbiome across all life stages, with B. pseudocatenulatum being a primary species found in adults. The Study Team highlighted that the specific strain ED02 was isolated from the fecal matter of a healthy adult after being enriched with the prebiotic xylooligosaccharides. To ensure the strain's safety for therapeutic use, the Study Team performed genome sequencing, which confirmed the absence of any virulence factors or antibiotic resistance genes. Furthermore, in vivo testing conducted by the Study Team demonstrated that ED02 provided significant health improvements in mice infected with hypervirulent Klebsiella pneumoniae. Throughout these trials, the Study Team observed no adverse events, supporting the potential of ED02 as a safe intervention for gastrointestinal and systemic health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
35
Probiotic Supplement
Matching placebo
People Science, Inc.
Los Angeles, California, United States
Impact and Tolerability
The primary objective of the study is to evaluate the impact and tolerability of the probiotic study product. This is measured by assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.
Time frame: 4 weeks
Gastrointestinal Symptoms
To evaluate the impact of the probiotic study product on gastrointestinal symptom rating. This will be measured by using changes in mean Gastrointestinal Symptom Rating Scale (GSRS) scores between placebo and study product groups during the study period.
Time frame: 6 weeks
Daily Gastrointestinal Symptoms
The goal is to evaluate the impact of the probiotic study product on daily gastrointestinal symptoms by using the changes in average scores of gastrointestinal symptoms (i.e. flatulence, bloating, abdominal discomfort) between placebo and study product group as measured by daily survey questions.
Time frame: 4 weeks
Impact on Gut Microbiota
To evaluate the impact of the probiotic study product on gut microbiota composition, diversity, and function assessed using metagenomic sequencing of fecal samples by using the changes from baseline to end treatment at Week 4 between study product and placebo group. Sample obtained at 2 weeks after the last dose will be compared as well.
Time frame: 6 weeks
Safety of Probiotic (Blood Hematology Profile)
To evaluate the impact of the probiotic on safety by using changes in blood parameters from baseline to end of treatment between placebo and probiotic study groups. Blood biomarkers assessed by Complete Blood Count (CBC).
Time frame: 4 weeks
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Safety of Probiotic (Blood Chemistry Profile)
To evaluate the impact of the probiotic on safety by using changes in blood biomarkers from baseline to end of treatment between placebo and probiotic study groups. Blood biomarkers assessed by Comprehensive Metabolic Panel (CMP).
Time frame: 4 weeks