Study design and primary objective
The clinical trial was IRB-approved, multicenter, randomized, double-blind, and placebo-controlled with two parallel arms (ClinicalTrials.gov identifier NCT04534036). Following a run-in period of 14 days, subjects were randomly assigned to an intervention and placebo arm for a duration of 84 days. “Constipated” was defined as having fewer than four WBMs, whereas “low WBMs” was a superset of this group, defined as having fewer than five WBMs. The primary objective of the study was to assess the change from baseline to day 84 in the weekly frequency of spontaneous bowel movements between subjects receiving placebo and those receiving a multistrain synbiotic.