The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

Exclusion Criteria

• •Infants born in multiple birth (i.e., twins, triplets, etc.)
• •Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
• •Infants with current evidence of failure to thrive, fever, or illness
• •Infants with any GI tract abnormalities
• •Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study
• •Infants who have consumed any probiotics since birth
• •Unwillingness to discontinue/avoid products used to treat IC (i.e., Simethicone, gripe water, colic drops, etc.) during the study. Note: consumption of IC products prior to the baseline period is NOT exclusionary
• •Maternal use of probiotics containing B. infantis during pregnancy, after the baby's birth and/or intent to use probiotics containing B. infantis at any time throughout the study
• •Maternal smoking or smoking within the home by any household member currently or during pregnancy
• •Mother following exclusionary diet due to her infant's colic (i.e., dairy elimination diet)
• •Any infant the Investigator deems to be ineligible for participation