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INF108F in Infants With Food Protein Induced Proctocolitis

NCT05793112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-13

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

INF108F probiotic

Oral suspension

DRUG

Placebo

Oral suspension

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-09
Primary Completion
2024-09-27
Completion
2024-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793112 on ClinicalTrials.gov