Title: “Safety and Tolerability of ShigActive™, a Shigella spp. Targeting Bacteriophage Preparation, in a Phase 1 Randomized, Double-Blind, Controlled Clinical Trial”
https://www.mdpi.com/2079-6382/13/9/858
Bacterial diseases of the GI tract are a major global cause of human illness and death. Among these, Shigella is one of the most common and deadly bacterial pathogens, causing approximately 125 million cases of shigellosis and around 14,000 deaths each year, with the majority occurring in children under 5 years old in developing countries. Traditional methods for preventing and treating shigellosis, such as vaccines and antibiotics, have been challenging. In a Phase 1 clinical trial, the safety and tolerability of ShigActive™, a lytic bacteriophage preparation targeting Shigella, were evaluated in ten participants who were given either ShigActive™ or a placebo with sodium bicarbonate orally three times a day for 7 days. During the 29-day observation period, half of the subjects who received ShigActive™ reported mild GI-related symptoms, while one experienced moderate fatigue. No serious adverse events occurred, and there were no significant differences in GI-related inflammatory mediators or fecal microbiome changes between the placebo and ShigActive™ groups. The results of this first-in-human trial demonstrate that ShigActive™ is safe and well tolerated when orally administered, with no significant differences compared to placebo controls.
PHAGElogist 