INF108F in Infants With Food Protein Induced Proctocolitis

Eligibility Criteria

• * Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks
• * Infants aged 1 - 90 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
• * 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