NCT03476447

Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants

Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants (The REMEDI Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Evolve BioSystems, Inc. · Industry
• Sex: All
• Age: 2 Months – 4 Months
• Healthy volunteers: Accepted

Summary

The REMEDI Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy term breastfed infants.

Detailed description

Mother-infant dyads will be enrolled when the infant is 2-4 months of age. A 1-week lead-in period will be utilized to collect baseline microbiome samples and for the completion of daily and weekly feeding and health logs. Subjects that meet eligibility criteria on Day 7 will be randomized into 1 of 4 treatment arms. Supplementation will begin on Day 8 and will continue for a total of 28 consecutive days. Subjects will be followed for an additional 4 weeks after the cessation of the supplement. The total duration of the study will be approximately 9 weeks. Infant stool and urine samples, as well as maternal breast milk samples, will be collected on multiple occasions during the study. Mothers will be asked to complete questionnaires and health logs during the course of the study as well.

Conditions

• Gut Microbiome

Interventions

Type	Name	Description
OTHER	B. infantis EVC001	A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.
OTHER	Lactose	A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.

Timeline

• Start date: 2018-04-06
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2018-03-26
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States