INF108F in Infants With Food Protein Induced Proctocolitis

Completed · Phase 4 · Has a placebo group

Conditions studied: Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis

In brief

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

Key facts

Study ID: NCT05793112
Run by: Massachusetts General Hospital
People needed: 20
Starts: 2023-09-09
Expected to finish: 2024-09-27
Last updated by the study team: 2026-03-13

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Newton Wellesley Hospital — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

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