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TerminatedNCT05129384COLICUpdated Aug 29, 2022

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

An interventional study of B. infantis EVC001 or Lactose Placebo in Infantile Colic, sponsored by Evolve BioSystems, Inc.. Terminated at 1 site in United States. Open to participants aged 14 Days to 42 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by Evolve BioSystems, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Company pursuing other research paths
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
14 Days to 42 Days
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Infantile Colic

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03

In context

Colic

127 studies on the registry are indexed under Colic; 18 are open to participants now.

This study's enrollment of 1 is below the median of 76 across 110 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Evolve BioSystems, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Days to 42 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • 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

Interventions

  • Dietary supplementB. infantis EVC001 or Lactose Placebo

    Infant probiotic

    Also known as: Lactose Placebo

06

What researchers measure

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

    Time frame: Baseline to Day 14

07

Study locations

1 site
  • Obvio Health
    Orlando, Florida 32817, United States
08

References and documents

Individual participant data

Plan to share: No — Our intent is to share group/averaged data for the cohorts to decrease risks associated with patient anonymity

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Jun 2022, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2021
First posted
Nov 22, 2021
StartActual
Feb 23, 2022
Primary completionActual
Jun 1, 2022
CompletionActual
Jun 1, 2022
Last update
Aug 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05129384
Lead sponsor
Evolve BioSystems, Inc.
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Feb 23, 2022
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Aug 29, 2022

Study contacts

Robin Flannery
study director · Evolve BioSystems
Parth Shah
principal investigator · Obvio Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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