INF108F in Infants With Food Protein Induced Proctocolitis

NCT05793112 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022P002752
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes to Gut Microbiome Composition

  Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).

  Baseline to Day 28

Secondary Outcomes (3)

• Changes to Clinical Symptoms of FPIAP

  Baseline to day 28

• Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log

  Enrollment to Study Day 14

• Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log

  Baseline, Study Day 7, Study Day 14, Study Day 28

Study Arms (2)

INF108F

EXPERIMENTAL

INF108F

Drug: INF108F probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

Oral suspension

Placebo

INF108F probiotic DRUG

Oral suspension

INF108F

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Limitations and Caveats

This study was a pilot study with a very limited sample size (n=20). Not all participants were per protocol of the study with the INF108 population having two participants (20%) considered not per protocol and the placebo having one participant (10%) not per protocol.

Results Point of Contact

• Title: Dr. Qian Yuan
• Organization: Massachusetts General Hospital

QYUAN@mgh.harvard.edu

6172435466

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 31, 2023
• Study Start: September 9, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: March 13, 2026
• Results First Posted: November 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)