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

NCT05129384 | Terminated

• 1 other identifier: EV-9101
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment

ACTIVE COMPARATOR

B. infantis EVC001 infant probiotic

Dietary Supplement: B. infantis EVC001 or Lactose Placebo

Placebo

PLACEBO COMPARATOR

Lactose

Dietary Supplement: B. infantis EVC001 or Lactose Placebo

Interventions

B. infantis EVC001 or Lactose Placebo DIETARY_SUPPLEMENT

Infant probiotic

Also known as: Lactose Placebo

Placebo; Treatment

Eligibility Criteria

• Age: 14 Days - 42 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Any infant the Investigator deems to be ineligible for participation

Sponsors & Collaborators

• Evolve BioSystems, Inc.: lead

Study Sites (1)

Obvio Health

Orlando, Florida, 32817, United States

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Robin Flannery

  Evolve BioSystems

  STUDY DIRECTOR

• Parth Shah

  Obvio Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, randomized, placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Infants will be randomized 1:1 to one of two study arms (treatment or placebo)

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: February 23, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)