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

Gut Microbiome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03476447
Study type Interventional
Source Evolve BioSystems, Inc.
Contact
Status Completed
Phase N/A
Start date April 6, 2018
Completion date April 3, 2019
View Details
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