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INF108F in Infants With Food Protein Induced Proctocolitis — RESTORE  

Infant Development Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05793112
Study type Interventional
Source Massachusetts General Hospital
Contact Arsal Khan, BA
Phone 617-643-8298
Email akhan51@mgh.harvard.edu
Status Recruiting
Phase Phase 4
Start date September 9, 2023
Completion date March 1, 2024
View Details
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