Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes to Gut Microbiome Composition
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 90 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
INF108F
INF108F
Intervention: INF108F probiotic (Drug)
Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Changes to Gut Microbiome Composition
Time Frame: Baseline to Day 28
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).
Secondary Outcomes
- Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log(Enrollment to Study Day 14)
- Changes to Clinical Symptoms of FPIAP(Baseline to day 28)
- 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)
Investigators
Qian Yuan, MD, PhD
Principal Investigator
Massachusetts General Hospital