NCT05129384

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

Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Evolve BioSystems, Inc. · Industry
• Sex: All
• Age: 14 Days – 42 Days
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. infantis EVC001 or Lactose Placebo	Infant probiotic

Timeline

• Start date: 2022-02-23
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-11-22
• Last updated: 2022-08-29

Locations

1 site across 1 country: United States