Phase 4
N=20
INF108F in Infants With Food Protein Induced Proctocolitis
Infant Development · Gut Microbiome · Food Protein Induced Allergic Proctocolitis
Bottom Line
View on ClinicalTrials.gov: NCT05793112 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Changes to Gut Microbiome Composition — 42.816; -12.413 Change in %B.infantis reads (Day 28-BL) — p=0.154
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- INF108F probiotic (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes to Gut Microbiome Composition |
42.816; -12.413 | 0.154 |
| SECONDARY Changes to Clinical Symptoms of FPIAP |
-5.5; 0.0 | 0.073 |
| SECONDARY Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log |
0; 2; 10; 8 | 0.471 |
| SECONDARY Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log |
2; 5; 1; 3; 4; 1 | 0.057 |
Summary
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05793112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.