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

NCT ID: NCT05129384

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2022-06-01

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.

Conditions

Infantile Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

B. infantis EVC001 infant probiotic

Group Type: ACTIVE_COMPARATOR

B. infantis EVC001 or Lactose Placebo

Intervention Type: DIETARY_SUPPLEMENT

Infant probiotic

Placebo

Lactose

Group Type: PLACEBO_COMPARATOR

B. infantis EVC001 or Lactose Placebo

Intervention Type: DIETARY_SUPPLEMENT

Infant probiotic

Interventions

B. infantis EVC001 or Lactose Placebo

Infant probiotic

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lactose Placebo

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

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 42 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Evolve BioSystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Flannery

Role: STUDY_DIRECTOR

Evolve BioSystems

Parth Shah

Role: PRINCIPAL_INVESTIGATOR

Obvio Health

Locations

Obvio Health

Orlando, Florida, United States

Countries

United States

Other Identifiers

EV-9101

Identifier Type: -

Identifier Source: org_study_id