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

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

To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic

Study Overview

• Status: Terminated
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: B. infantis EVC001 or Lactose Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32817
      • Obvio Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Lactose	Dietary supplement: B. infantis EVC001 or Lactose Placebo; Infant probiotic; Other Names: Lactose Placebo
Active Comparator: Treatment; B. infantis EVC001 infant probiotic	Dietary supplement: B. infantis EVC001 or Lactose Placebo; Infant probiotic; 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

Collaborators and Investigators

• Sponsor: Evolve BioSystems, Inc.
• Investigators: Study Director: Robin Flannery, Evolve BioSystems; Principal Investigator: Parth Shah, Obvio Health

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: EV-9101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Our intent is to share group/averaged data for the cohorts to decrease risks associated with patient anonymity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No