drugset
drugset / Trial / NCT05793112

INF108F in Infants With Food Protein Induced Proctocolitis

NCT05793112 ↗

Phase 4 Completed 20 enrolled Massachusetts General Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2023-09-09
Primary completion
2024-09-27
Completion
2024-09-27

Outcome

Missed primary endpoint

registry analysis (superiority test); INF108F vs Placebo; p = 0.154; Median Difference (Final Values) 57.57; Wilcoxon range sum test NCT05793112 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject INF108F Other / unclassified — Oral

Indications

food protein-induced allergic proctocolitis