Seed Health Presents New Clinical Trial Data: DS-01® Increases Two Key Microbiome Molecules Linked to Gut, Metabolic, Immune, and Cellular Health

DS-01® is the first broad-spectrum synbiotic clinically shown to increase production of both Urolithin A and butyrate—two key microbial metabolites linked to whole-body health

Presented at Digestive Disease Week® (DDW) 2025, the findings expand DS-01®'s clinical foundation and reinforce the potential of microbiome-targeted products to impact multiple biological systems

BOSTON, May 5, 2025 /PRNewswire/ -- Microbiome science company Seed Health presented clinical data on its flagship innovation, DS-01® Daily Synbiotic, at Digestive Disease Week® (DDW) 2025. Findings from a randomized, placebo-controlled clinical trial in healthy adults demonstrated that DS-01® increased production of two key microbial metabolites—Urolithin A and butyrate—implicated in gut barrier function, metabolism, and healthy aging. The trial also found reductions in C-Reactive Protein (CRP), a widely used marker of systemic inflammation, suggesting DS-01®'s potential to influence immune pathways. The findings underscore DS-01®'s impact beyond microbial composition, demonstrating measurable biological function through the production of microbiome-mediated metabolites.

The company presented two posters during the "Prebiotics, Probiotics and Synbiotics in Health and Disease" session.

Presentation Highlights

1. Effects of a novel, broad-spectrum synbiotic on Urolithin A production: A randomized, placebo-controlled clinical trial
   This randomized, placebo-controlled clinical trial evaluated DS-01® for its ability to increase production of Urolithin A—a microbiome-derived metabolite linked to mitochondrial function, cellular energy, metabolic health, intestinal barrier integrity, and healthy aging. DS-01® provides the natural machinery to produce Urolithin A, delivering both a polyphenol precursor in its prebiotic outer capsule and key microbes in its probiotic inner capsule.
    
   Overall, this is the first study to demonstrate that a broad-spectrum synbiotic can increase Urolithin A production in humans. Key findings include:
    
   
   • Rapid and Sustained Urolithin A Increase: DS-01® increased urinary Urolithin A levels by approximately 100-fold by Day 7 (P<0.0001), with levels sustained through Day 91.
   • 100% Conversion to Urolithin A Producers: By Day 91, 100% of participants in the DS-01® arm became Urolithin A producers, compared to 44% in the placebo arm (P<0.01).
   • Increased Lactobacillus spp. Abundance: DS-01® significantly increased the abundance of specific Lactobacillus species known to convert dietary polyphenols into Urolithin A precursors through Day 91 (P<0.001).
   
   
   
2. A novel, broad-spectrum synbiotic increases butyrate production and decreases CRP: A randomized, placebo-controlled clinical trial 
   This randomized, placebo-controlled trial evaluated DS-01® for its impact on butyrate and CRP. Butyrate is a key short-chain fatty acid (SCFA) produced by the gut microbiome, which fuels the cells that line the colon and supports immune function, gut barrier integrity, and metabolic signaling. CRP is a systemic marker of inflammation.
    
   The study is among the first to show that a broad-spectrum synbiotic can significantly increase butyrate levels in humans. Key findings include:
   
   
   • Increased Butyrate Production: The synbiotic significantly increased fecal butyrate levels through Day 91 (P<0.03) in participants with low baseline butyrate levels; no change was observed in the placebo arm.
   • Reduction in a Key Systemic Inflammatory Marker: There was a reduction in CRP, a marker of systemic inflammation, associated with the colonization of DS-01® species through Day 91 (P<0.02).
   • Enhanced Microbiome Diversity: Participants in the synbiotic arm showed significantly higher diversity of Bifidobacterium and Lactobacillus species at all time points compared to placebo through Day 91 (P<0.0001).

"This represents the first time a broad-spectrum synbiotic has been clinically shown to increase both Urolithin A and butyrate in humans," said Zain Kassam, M.D., M.P.H., Chief Medical Officer at Seed Health. "DS-01® is delivering measurable biological impact via the microbiome—driving the production of key metabolites long studied for their roles in gut barrier integrity, inflammation, and healthy aging. These findings expand the biological relevance of DS-01® and point to new applications of microbiome-targeted innovations in advancing systemic health."

About Seed Health
Seed Health is a microbiome science company pioneering innovations in probiotics and living medicines to impact human and planetary health. Founded to realize the potential of the microbiome, our platform enables the translation of breakthrough science across a portfolio targeting health outcomes from infancy to aging. Our consumer innovations are commercialized under Seed® —an award-winning, science-first brand known for clinically validated innovations in probiotics. Our pipeline encompasses both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin, pediatrics, mental health, metabolic function, and nutrition. Our environmental research is conducted under SeedLabs, which was founded to advance novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity.

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SOURCE Seed Health