INF108F in Infants With Food Protein Induced Proctocolitis

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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