Randomized, placebo-controlled clinical design.
ADVERSE EVENTS
CONSORT diagram indicating clinical trial design and execution.Cohort characteristics.Allocation, randomization, blocking, and blinding were executed by a Contract Research Organization. 1:1 randomization was done via a computer-generated sequence (with the expectation of normal age distribution in the active and placebo groups) using two strata (male vs. female) and block sizes of 2, 4, and 6. The randomization resulted in 43 subjects in the synbiotic arm and 48 receiving placebo. Parents reported in a logbook the daily frequency and consistency of their child’s stool and any adverse events or use of medications. The subjects were asked to not consume any additional probiotic supplements or foods during the study period. WBMs were reported to the study coordinators twice weekly throughout the 84-day intervention period. While first-dosing was administered in 91 children, 27 children did not complete through day 84. These study participants or their legal guardian(s) received a termination notice upon which clinical product or placebo was returned to the study coordinator for prompt disposal. All data for these non-completing 27 children at baseline were dropped from the analysis and baseline microbiome samples were destroyed.