Seed Health launches pediatric synbiotic supported by RCT
The PDS-08 Pediatric Daily Synbiotic is described as a two-in-one powdered synbiotic. Each of the nine probiotic strains are supported by published dose-response data. The prebiotic is a comprised of short and long-chain fibers.
In addition to 18 clinical studies validating strain-specific benefits across gut barrier integrity, gut immune function, dermatological health, and respiratory health, PDS-08 was also the subject of a placebo-controlled, randomized clinical trial recently published online on the pre-peer review MedRxiv site. The pre-print is currently undergoing peer review at a top-tier scientific journal.
The new trial included 64 children aged between 3 and 17 who were randomly assigned to receive either the synbiotic composition or placebo (n=31) for 84 days. The trial analysis employed state-of-the-art bioinformatics from the Mason Lab at Weill Cornell Medicine, which specializes in next-generation sequencing, functional genomics, and algorithms to elucidate human disease mechanisms.
Data from the study showed that children experiencing intermittent constipation (less than 5 bowel movements a week) saw an increase in weekly bowel movements without any observed side effects or gastro-intestinal (GI) distress (such as pain, bloating, gas, diarrhea). This is considered a significant finding considering as many as 30% of children struggle with intermittent, constipation-related GI distress.
The product is also reported to be the first multi-strain synbiotic to include the pioneering strains, Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706), which were evaluated in a randomized, placebo-controlled, double-blind trial in over 400 school aged children with respiratory difficulties.
According to data published in the Journal of Immunology Research, a 16-week intervention with L. salivarius LS01 and B. breve B632 led to significant improvements in airway response in children with respiratory difficulties and reduced frequency of drug-based intervention to treat said difficulties.
The other strains used in the PDS-08 product are: Bifidobacterium breve BR03, B. lactis BPL1, B. longum ES1, Lacticaseibacillus (formerly Lactobacillus) casei BPL4, L. rhamnosus GG, Lactobacillus acidophilus NCFM, and B. animalis subsp. lactis Bi-07.
"Over the last decade, the velocity of microbiome science discoveries that transform our understanding of each phase and aspect of a child's health is unprecedented,” stated Raja Dhir, Co-CEO and Co-Founder of Seed. "With advanced bioinformatics, and unique clinical endpoints, and novel bioinformatics, we now have a deeper understanding of the pediatric microbiome to unlock novel applications for probiotics."
Dr. James Versalovic, Pathologist-in-Chief at Texas Children's Hospital, Director of Texas Children's Microbiome Center, Seed Health Scientific Board member, and second author on the new MedRxiv paper, added: "With a greater understanding of the pediatric microbiome – and how probiotic interventions can be used to support it – we can deliver on the promise of probiotics by advancing clinically studied interventions with validated doses and protocols, coupled with improved outcomes for infants and children.”
PDS-08 is the company's first consumer launch since the announcement of its $40 million Series A last year and marks Seed’s entry into the fast-growing global children’s health and wellness market.
Available by subscription for $39.99/month at the company’s website, the product does not require refrigeration and is free from sugar, artificial colorants, flavors, preservatives and 14 classes of allergens.
"While there is evidence to support probiotic intervention for select pediatric conditions, the marketing and commercialization are often ahead of the science. In a sea of hyperbolic claims and misinformation, choosing the right probiotic for your child can feel paralyzing,” explained Ara Katz. Co-CEO and Co-Founder.
“With PDS-08, we set out to develop a clinically validated pediatric product to elevate the category and offer a science-first option that parents and pediatricians can trust.”
The PDS-08 Pediatric Daily Synbiotic joins Seed's flagship synbiotic for adults, DS-01 Daily Synbiotic, which was developed with Dr Gregor Reid, Seed Health's Scientific Advisor, past-President of the International Scientific Association of Probiotics and Prebiotics (ISAPP), and former Chair of the UN-World Health Organization Expert Panel that authored the global scientific definition of probiotics.
DS-01 is described as a “broad-spectrum probiotic with 24 genetically distinct microorganisms across 12 species, including strains with novel mechanistic data that have been investigated in multiple randomized, double-blind, placebo-controlled human clinical trials”.
Available as a dietary supplement, the company recently received IND authorization for a clinical trial in IBS patients with Dr. Anthony Lembo at Harvard Medical School. It is also being studied in additional clinical trials to evaluate efficacy in endpoints related to constipation, post-alcohol gut microbiota restoration, urolithin production, and recovery after broad-spectrum antibiotics.
Pre-print published online, not yet peer reviewed. doi: 10.1101/2022.04.07.22273329
“Functional response to a microbial synbiotic in the gastrointestinal system of constipated children”
Authors: B.T. Tierney, et al.