CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
INF108F probiotic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05793112
NCT05793112Phase 4Completed
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Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis

Massachusetts General Hospital·interventional·Posted Mar 31, 2023·Updated Mar 13, 2026

In Brief

A Phase 4 clinical trial evaluating INF108F probiotic and Placebo for Infant Development and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedMar 31, 2023
Enrollment StartSep 9, 2023
Primary CompletionSep 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.3 years ago

Interventions

INF108F probioticdrug

Oral suspension

Placebodrug

Oral suspension