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

NCT05129384 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-08-29

No results posted yet for this study

Summary

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

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

B. infantis EVC001 or Lactose Placebo

Infant probiotic

Sponsors & Collaborators

  • Evolve BioSystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Robin Flannery · Evolve BioSystems

  • Parth Shah · Obvio Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
42 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129384 on ClinicalTrials.gov