Seed Health, a microbiome science company pioneering innovations in probiotics, presented clinical data on its flagship DS-01 Daily Synbiotic, at Digestive Disease Week (DDW) 2025 in San Diego, CA.

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 company said.

The trial also found reductions in C-Reactive Protein (CRP), a 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 said.

“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, MD, MPH, 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.”

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. DS-01 delivers 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, the company claimed. 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).