INF108F in Infants With Food Protein Induced Proctocolitis

Phase 4

Recruiting

• Conditions: Infant Development; Gut Microbiome; Food Protein Induced Allergic Proctocolitis
• Interventions: Drug: Placebo; Drug: INF108F probiotic

• Registration Number: NCT05793112
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Study Start: 2023-09-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
INF108F	INF108F probiotic	INF108F

Primary Outcome Measures

Name	Time	Method
Changes to gut microbiome composition	Baseline to Day 28	Changes to the gut microbiome composition in infants with FPIAP over a 4-week period. We will analyze the 16S rRNA of the gut microbiome as well as the short-gun sequencing of metagenomic species of the gut microbiome

Secondary Outcome Measures

Name	Time	Method
Changes to clinical symptoms of FPIAP	Baseline to day 28	Changes to clinical symptoms of FPIAP, specifically we will collect information using questionnaire about infants' GER symptoms, feeding, sleep and stool frequency and consistency. The severity of GER will be quantified using the Infant GER Questionnaire (I-GERQ), with numeric scores, the higher score means more severe GER, the maximum score is 25, scores \>7 provide 74% specificity and 94% sensitivity for diagnosing GERD. The sleep will be captured using Infant Sleep Questionnaire, with 0-10 scales, 0 means worst sleep and 10 means excellent sleep for quantify the quality of infant's night sleep.

Trial Locations

Locations (1)

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States