PREVENT study: Probiotics for EVEry Newborn vs. Treatment-as-Needed Comparative Effectiveness Trial

By: Dr. Patricia Parkin, Hospital for Sick Children


One in five infants experience colic, which is associated with excessive cry/fuss. Despite more than 50 years of research, the cause of colic is unknown. Recent technological advancements and emerging evidence points to the role of the microbiome. Some research shows that giving babies probiotics can prevent colic in some infants. Other research has shown that probiotics can also be effective in treating colic after babies develop it. 

Objective and Trial Procedure 

The aim of the study is to compare prevention (probiotic given to newborns within the first week of life for 12 weeks) with treatment-as-needed (probiotic given, to infants who develop excessive cry/fuss up to 12 weeks of age).  This is a single site pilot study to assess feasibility for a full trial.  The results are expected to inform a multi-centered trial.
Information will be gathered from participants at 3 time points during the first 4 months of baby’s life. We will track infant crying and sleep, parent fatigue and mental health and analyze a sample of the infant’s stool. Additionally, we will contact participants briefly once per week by phone/video to ask a few questions.

Importance of the trial:

Helping babies with colic is important as it may help avert potentially serious and costly consequences associated with excessive crying including maternal postpartum depression, insecure attachment style, reduced breastfeeding duration, behavioural problems in later childhood, healthcare system burden, and importantly in some circumstances, shaken baby syndrome.