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First peer-reviewed placebo-controlled trial to demonstrate probiotic enrichment and clinical efficacy of a multi-strain synbiotic in children with intermittent constipation
LOS ANGELES, Nov. 2, 2022 /PRNewswire/ -- Seed Health, a microbiome science company pioneering innovations in probiotics, today announced the publication of a double-blind, placebo-controlled clinical study in Pediatric Research (Nature Portfolio) –– the official journal of the American Pediatric Society, the European Society for Paediatric Research, and the Society for Pediatric Research. The study demonstrates the clinical potential of Seed Health's first pediatric synbiotic offering, PDS-08™ Pediatric Daily Synbiotic, in children with intermittent constipation. Christopher E. Mason, Ph.D., Professor of Physiology and Biophysics at Weill Cornell Medicine, led the bioinformatics analysis, including the generation of novel insights into the role of the gut microbiome in pediatric gastrointestinal (GI) health.
Childhood constipation is a significant health problem, with as many as 30% of children worldwide struggling with the pain, discomfort and psychological stress of intermittent constipation. This does not account for the many more who experience stool withholding and general stool-related anxiety. In the U.S. alone, related healthcare costs total approximately $3.9 billion per year. Existing treatments rely on unsustainable options like laxatives and stimulants, which often cause uncomfortable side effects, including excessive gas, bloat, cramping or abdominal pain. These new findings highlight the potential of PDS-08™ as an alternative or complement to existing treatment paradigms for parents and pediatricians.
Children with intermittent constipation (less than five weekly bowel movements, or WBMs) experienced an increase in regular, healthy WBMs while taking PDS-08™. Children in this group were also four times as likely to experience an increase of two WBMs, compared to placebo. No adverse effects or accompanying GI distress (as commonly reported with many fiber-based dietary supplements, probiotics, and high-dose fermentable prebiotics) were observed in any participants.
"While previous research has suggested that probiotic intervention may affect the GI system in a pediatric population, data have been inconsistent, with most studies conducted in neither a randomized nor placebo-controlled setting," said paper co-author Dr. James Versalovic, Pathologist-in-Chief at Texas Children's Hospital, Director of Texas Children's Microbiome Center and Seed Health Scientific Board member. "These findings represent the next frontier in probiotics and deepen our understanding of the pediatric gut microbiome."
Through metagenomic shotgun sequencing, PDS-08™ was shown to significantly enrich Bifidobacterium, a genus of bacteria native to healthy infants, linked to the maintenance and improvement of digestive and immune function in the pediatric gut microbiome. Sequencing also demonstrated the persistence of all probiotic species over the course of treatment. By measuring both probiotic enrichment and functional outcomes, PDS-08™ was shown to support healthy GI function and regularity in a pediatric population.
"Gut microbiome composition plays an essential role in bowel movement regulation, but existing solutions do not consider nor target this pathway," said Raja Dhir, Seed Health co-founder and contributing author of the study. "With sophisticated computational analysis and robust clinical testing, we unlock a greater understanding of microbial ecology and how we might leverage microbial innovations to address some of our most pressing and unmet needs for both adults and children."
"As a parent, I know how physically and emotionally detrimental GI symptoms can be for children, and how challenging it can be to find a solution that works," said Ara Katz, Seed Health co-founder. "We're inspired to not only advance the scientific rigor in children's probiotics, but to also introduce an intervention with the potential to meaningfully impact the quality of life for children, caregivers and families."
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 microbes, our platform enables the translation of breakthrough science across a portfolio encompassing both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin and oral care, pediatrics, mental health, metabolic function and nutrition. Our consumer innovations are commercialized under Seed® with a mission to bring much-needed precision, efficacy, education, and perspective-shifting science communication to the global category of probiotics. Environmental research is conducted under SeedLabs, which was founded to develop novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity.
LUCA Biologics, Seed Health's biotechnology company co-founded with Dr. Jacques Ravel, develops living medicines targeting the vaginal microbiome for urogenital and reproductive health.
SOURCE Seed Health