Clinical trial NCT05793112: INF108F in Infants With Food Protein Induced Proctocolitis
Official title: Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infant Development
Gut Microbiome
Food Protein Induced Allergic Proctocolitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes to gut microbiome composition
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Changes to clinical symptoms of FPIAP
timeFrame: Baseline to day 28
Other outcomes:
Locations:
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
Study officials:
References:
citation: Martin VM, Virkud YV, Seay H, Hickey A, Ndahayo R, Rosow R, Southwick C, Elkort M, Gupta B, Kramer E, Pronchick T, Reuter S, Keet C, Su KW, Shreffler WG, Yuan Q. Prospective Assessment of Pediatrician-Diagnosed Food Protein-Induced Allergic Proctocolitis by Gross or Occult Blood. J Allergy Clin Immunol Pract. 2020 May;8(5):1692-1699.e1. doi: 10.1016/j.jaip.2019.12.029. Epub 2020 Jan 7.
citation: Martin VM, Virkud YV, Phadke NA, Su KW, Seay H, Atkins MR, Keet C, Shreffler WG, Yuan Q. Increased IgE-Mediated Food Allergy With Food Protein-Induced Allergic Proctocolitis. Pediatrics. 2020 Sep;146(3):e20200202. doi: 10.1542/peds.2020-0202. No abstract available.
citation: Radano MC, Yuan Q, Katz A, Fleming JT, Kubala S, Shreffler W, Keet CA. Cesarean section and antibiotic use found to be associated with eosinophilic esophagitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):475-477.e1. doi: 10.1016/j.jaip.2014.02.018. Epub 2014 May 1. No abstract available.