Symptomatic relief from at-home use of activated Bifidobacterium infantis EVC001 probiotic in infants: results from a consumer survey on the effects on diaper rash, colic symptoms, and sleep

Abstract
The gut microbiome during infancy is directly involved in the digestion of human milk, development of the immune system, and long-term health outcomes. Gut dysbiosis in early life has been linked to multiple short-term ailments, from diaper dermatitis and poor stooling habits, to poor sleep and fussiness, with mixed results in the scientific literature on the efficacy of probiotics for symptom resolution. Despite the growing interest in probiotics for consumer use, observed symptomatic relief is rarely documented. This study aims to evaluate observed symptomatic relief from at-home use of activated Bifidobacterium infantis EVC001 in infants. Consumer feedback was collected over a 2-year period via a 30-day post-purchase online survey of B. infantis EVC001 (Evivo®) customers. Outcome measures included observed changes in diaper rash, symptoms of colic, and sleep behaviours in infants fed B. infantis EVC001. A total of 1,621 respondents completed the survey. Before purchasing B. infantis EVC001, the majority of respondents visited the product website, researched infant probiotics online, or consulted with their doctor or other healthcare professional. Of the participants whose infants had ever experienced diaper rash, 72% (n=448) reported improvements, and 57% of those reported complete resolution of this problem. Of those who responded to questions about gassiness/fussiness, naptime sleep, and night-time sleep behaviours, 63% (n=984), 33% (n=520), and 52% (n=806) reported resolution or improvements, respectively. Although clinical data regarding probiotic use are often inconclusive for symptom resolution, home use of B. infantis EVC001 in infants improved diaper rash, gassiness/fussiness, and sleep quality within the first week of use in a significant number of respondents who engaged in a voluntary post-purchase survey. These outcomes may be a result of the unique genetic capacity of B. infantis EVC001 to colonise the infant gut highlighting the importance of strain selection in evaluating the effects of probiotic products.