NCT05793112

INF108F in Infants With Food Protein Induced Proctocolitis

Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 90 Days
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Infant Development
• Gut Microbiome
• Food Protein Induced Allergic Proctocolitis

Interventions

Type	Name	Description
DRUG	INF108F probiotic	Oral suspension
DRUG	Placebo	Oral suspension

Timeline

• Start date: 2023-09-09
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2023-03-31
• Last updated: 2026-03-13
• Results posted: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study