MedTrace Logo

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

NCT03476447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-19

No results posted yet for this study

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.

Conditions

  • Gut Microbiome

Interventions

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.

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Evolve BioSystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Smilowitz, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2019-04-03
Completion
2019-04-03

Countries

  • United States

Study Locations

More Related Trials

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 NCT03476447 on ClinicalTrials.gov