The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

Study Overview
=================
Brief Summary
-----------------
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic

Detailed Description
-----------------
There is evidence to support that B. infantis EVC001 supplementation may ameliorate symptoms associated with colic by establishing and maintaining the necessary gut microbial composition to promote proper barrier and immune function in infants. The primary objective of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic from Baseline to Day 14.

Official Title
-----------------
Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

Conditions
-----------------
Infantile Colic

Intervention / Treatment
-----------------
* Dietary Supplement: B. infantis EVC001 or Lactose Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with a diagnosis of infantile colic per Rome IV criteria and reported to cry/fuss for ≥ 3 hours/day, within a 24-hour period as determined by the 24-hour cry/fuss eDiary AND 24 hours of LENA vocalizations Infants with a gestational period of ≥ 37 to 42 weeks Infants between 14 and ≤ 42 days of life at the completion of screening/baseline tasks Infants exclusively breastfed for at least 7 days immediately prior to enrollment and with mother's intent to continue feeding breast milk exclusively for the duration of the study Mothers willing to use their own electronic device(s) to download and utilize all required study software (decentralized trial platform on a mobile device and the LENA device software on a Windows 10 or higher laptop or desktop that has at least 10 GB of free space and fast, reliable internet) Mother is fluent in English Exclusion Criteria: Infants born in multiple birth (i.e., twins, triplets, etc.) Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies) Infants with current evidence of failure to thrive, fever, or illness Infants with any GI tract abnormalities Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study Infants who have consumed any probiotics since birth Unwillingness to discontinue/avoid products used to treat IC (i.e., Simethicone, gripe water, colic drops, etc.) during the study. Note: consumption of IC products prior to the baseline period is NOT exclusionary Maternal use of probiotics containing B. infantis during pregnancy, after the baby's birth and/or intent to use probiotics containing B. infantis at any time throughout the study Maternal smoking or smoking within the home by any household member currently or during pregnancy Mother following exclusionary diet due to her infant's colic (i.e., dairy elimination diet) Any infant the Investigator deems to be ineligible for participation

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 42 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Infants will be randomized 1:1 to one of two study arms (treatment or placebo)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>B. infantis EVC001 infant probiotic | Dietary Supplement: B. infantis EVC001 or Lactose Placebo<br>* Infant probiotic<br>* Other names: Lactose Placebo;|
| Placebo Comparator: Placebo<br>Lactose | Dietary Supplement: B. infantis EVC001 or Lactose Placebo<br>* Infant probiotic<br>* Other names: Lactose Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in crying/fussing duration | Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic | Baseline to Day 14 |