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Probiotic
Treatment for Infantile Colic (COLIC Trial)
N/A
Waitlist Available
Led By Parth Shah
Research Sponsored by Evolve BioSystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 14
Awards & highlights
COLIC Trial Summary
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic
Eligible Conditions
- Infantile Colic
COLIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOLIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in crying/fussing duration
COLIC Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
B. infantis EVC001 infant probiotic
Group II: PlaceboPlacebo Group1 Intervention
Lactose
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Who is running the clinical trial?
Evolve BioSystems, Inc.Lead Sponsor
7 Previous Clinical Trials
704 Total Patients Enrolled
Robin FlanneryStudy DirectorEvolve BioSystems
1 Previous Clinical Trials
231 Total Patients Enrolled
Parth ShahPrincipal InvestigatorObvio Health
4 Previous Clinical Trials
977 Total Patients Enrolled
Frequently Asked Questions
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