INF108F in Infants With Food Protein Induced Proctocolitis

Massachusetts General Hospital20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Infant Development Gut Microbiome Food Protein Induced Allergic Proctocolitis

Interventions

INF108F probioticDRUG

Oral suspension

PlaceboDRUG

Oral suspension

Eligibility

Sex: ALLMin age: 1 DayMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Newton Wellesley Hospital

Newton, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline to Day 28

Secondary Outcomes

Changes to Clinical Symptoms of FPIAP

We will collect information using questionnaires about infants' gastroesophageal reflux disease symptoms, feeding, sleep and stool frequency and consistency. The severity of infant GER will be quantified using the Infant Gastroesophageal Reflux Questionnaire (I-GERQ), with numeric scores. The minimum score is 0 and the maximum score is 25; scores \>7 provide 74% specificity and 94% sensitivity for diagnosing GERD. Higher I-GERQ scores/values are indicative of worse outcomes, worse reflux symptoms for the infant. The secondary outcome was reported as the absolute change from baseline in I-GERQ score; therefore, a higher value would be positive as the score is reduced significantly from baseline, which means reflux symptoms were improved. 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.

Time frame: Baseline to day 28

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

Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.