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

Primary Purpose

Infantile Colic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B. infantis EVC001 or Lactose Placebo
Sponsored by
Evolve BioSystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic

Eligibility Criteria

14 Days - 42 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Obvio Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

B. infantis EVC001 infant probiotic

Lactose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 10, 2021
Last Updated
August 24, 2022
Sponsor
Evolve BioSystems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05129384
Brief Title
The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
Acronym
COLIC
Official Title
Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Company pursuing other research paths
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evolve BioSystems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Infants will be randomized 1:1 to one of two study arms (treatment or placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind, randomized, placebo-controlled study
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
B. infantis EVC001 infant probiotic
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lactose
Intervention Type
Dietary Supplement
Intervention Name(s)
B. infantis EVC001 or Lactose Placebo
Other Intervention Name(s)
Lactose Placebo
Intervention Description
Infant probiotic
Primary Outcome Measure Information:
Title
Change in crying/fussing duration
Description
Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic
Time Frame
Baseline to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
42 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Flannery
Organizational Affiliation
Evolve BioSystems
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Parth Shah
Organizational Affiliation
Obvio Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obvio Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Our intent is to share group/averaged data for the cohorts to decrease risks associated with patient anonymity

Learn more about this trial

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

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