As many as 30 percent of children worldwide struggle with constipation, which causes pain, discomfort, and even psychological stress. A new double-blind, placebo-controlled clinical study in Pediatric Research offers hope for this common children’s health condition.
For the study, children with intermittent constipation (less than five weekly bowel movements, or WBMs) who were given the supplement PDS-08 Pediatric Daily Synbiotic (PDS-08) experienced an increase in regular, healthy WBMs. Children in the treatment group were also four times as likely to have an increase of two WBMs compared to those in the placebo group. No adverse effects or symptoms of GI distress (reported with many fiber-based dietary supplements, probiotics, and high-dose fermentable prebiotics) were reported.
“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.”
PDS-08 — a blend of 9 probiotic strains and a fiber-based prebiotic made by Seed Health — offers an alternative or complementary treatment to existing treatment paradigms (e.g., laxatives or stimulants) for parents and pediatricians. And unlike existing treatments, PDS-08 has not been shown to cause side effects such as excessive gas, bloating, cramping, or abdominal pain.
“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.”
Conclusion
This placebo-controlled, randomized clinical trial demonstrated that a novel synbiotic formulation increased weekly WBMs in children who had low-frequency WBMs at baseline. We additionally characterized the microbiome in individuals who received and responded to treatment versus those who did not, identifying microbial richness as an indicator of a high likelihood of response to treatment. Only a fraction of studies that evaluate the impact of microbial therapy on human health is executed in a placebo-controlled or randomized setting. While useful in many ways, non-randomized study designs are not able to test a fundamental causal link between treatment and disease. Moreover, high placebo response rates are typically observed in gastrointestinal trials with subjective endpoints due to the potential effects of stress, belief, and other psychosomatic influences on the gastrointestinal system and symptomology. In the case of adult IBS, for example, placebo response rates up to 40% are typically observed.
