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NCT05129384 | Terminated | Infantile Colic

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

Evolve BioSystems, Inc.

Brief Summary:

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

Condition or disease

Infantile Colic

Intervention/treatment

B. infantis EVC001 or Lactose Placebo

Phase

Not Applicable

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
Estimated Enrollment : 1 participants
Masking : Quadruple
Masking Description : This is a double-blind, randomized, placebo-controlled study
Primary Purpose : Treatment
Official Title : Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
Actual Study Start Date : February 23, 2022
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022
Arm Intervention/treatment

Active Comparator: Treatment

B. infantis EVC001 infant probiotic

Dietary Supplement: B. infantis EVC001 or Lactose Placebo

Placebo Comparator: Placebo

Lactose

Dietary Supplement: B. infantis EVC001 or Lactose Placebo
Ages Eligible for Study: 14 Days to 42 Days
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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
The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Obvio Health

Orlando, florida, United States, 32817