INF108F in Infants With Food Protein Induced Proctocolitis (RESTORE)

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Food Protein Induced Allergic Proctocolitis

Gut Microbiome

Infant Development

Treatments

Drug: Placebo

Drug: INF108F probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT05793112

2022P002752

Details and patient eligibility

About

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

Full description

This is a single-center, randomized, double-blind, placebo-controlled trial with two arms evaluating IBF108F in breastfed infants with FPIAP. Assessments will be conducted over a 4-week study period with assessment of blood in stool, infant stooling, sleep, feeding, and growth. Safety will be evaluated through collection adverse events.

Enrollment

20 patients

Sex

All

Ages

1 to 90 days old

Volunteers

Accepts Healthy Volunteers

Inclusion 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

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