INF108F in Infants With Food Protein Induced Proctocolitis

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

Detailed Description
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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.

Official Title
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Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis

Conditions
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Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis

Intervention / Treatment
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* Drug: INF108F probiotic
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INF108F<br>INF108F | Drug: INF108F probiotic<br>* Oral suspension<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to gut microbiome composition | 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 | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to clinical symptoms of FPIAP | 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. | Baseline to day 28 |