INF108F in Infants With Food Protein Induced Proctocolitis (RESTORE)

Inclusion Criteria: Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks Infants aged 1 - 60 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature Exclusion Criteria: Infants born earlier than 37 weeks of gestation Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies) Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system Antibiotic use (oral or systemic) within 7 days prior to enrollment Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT) Infants who have consumed any B. infantis-containing probiotics since birth