NCT07423897

Consumer Health Study Aims to Evaluate the Safety, Tolerability and Impact of ED02 Probiotic Supplement on Gastrointestinal Outcomes

A Randomized, Double-Blind, Placebo-Controlled Pilot Study Evaluating the Safety, Tolerability and Impact of Synbiotic Health's Bifidobacterium Pseudocatenulatum ED02 Probiotic Supplement on Gastrointestinal Outcomes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Synbiotic Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal
• Gut Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium pseudocatenulatum	Probiotic Supplement
DIETARY_SUPPLEMENT	Placebo	Matching placebo

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-06-17
• Completion: 2026-08-31
• First posted: 2026-02-20
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States