INF108F in Infants With Food Protein Induced Proctocolitis

NCT ID: NCT05793112

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-09
• Study Completion Date: 2024-09-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

INF108F

INF108F

Group Type: EXPERIMENTAL

INF108F probiotic

Intervention Type: DRUG

Oral suspension

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral suspension

Interventions

INF108F probiotic

Oral suspension

Intervention Type: DRUG

Placebo

Oral suspension

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks
• Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes
• Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk
• A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature

Exclusion Criteria

• Infants born earlier than 37 weeks of gestation
• Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment
• Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
• Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency
• History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system
• Antibiotic use (oral or systemic) within 7 days prior to enrollment
• Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study
• Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT)
• Infants who have consumed any B. infantis-containing probiotics since birth

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qian Yuan, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Newton Wellesley Hospital

Newton, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022P002752

Identifier Type: -

Identifier Source: org_study_id