NCT03476447

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

March 19, 2018

Last Update Submit

April 17, 2019

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (1)

  • Fecal B. infantis levels in infants at 28 days - difference between B. infantis and placebo

    The difference in levels of infant fecal B. infantis (as measured by B. infantis qPCR) between B. infantis EVC001 supplementation and placebo supplementation on Day 28.

    28 days

Secondary Outcomes (1)

  • Fecal B. infantis levels in infants at 28 days - difference between B. infantis doses

    28 days

Study Arms (4)

High dose B. infantis EVC001

ACTIVE COMPARATOR

10 participants will receive powdered B. infantis EVC001 at a high dose per daily oral feeding

Other: B. infantis EVC001

Medium dose B. infantis EVC001

ACTIVE COMPARATOR

10 participants will receive powdered B. infantis EVC001 at a medium dose per daily oral feeding

Other: B. infantis EVC001

Low dose B. infantis EVC001

ACTIVE COMPARATOR

10 participants will receive powdered B. infantis EVC001 at a low dose per daily oral feeding

Other: B. infantis EVC001

Lactose Placebo

PLACEBO COMPARATOR

10 participants will receive powdered lactose per daily oral feeding

Other: Lactose

Interventions

B. infantis EVC001OTHER

A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.

High dose B. infantis EVC001Low dose B. infantis EVC001Medium dose B. infantis EVC001
LactoseOTHER

A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.

Lactose Placebo

Eligibility Criteria

Age2 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age of subjects: Infants: 60 to 125 days old, Mothers: 21 years old and greater
  • Mother-infant dyads who live within a 40-mile radius from the clinical site
  • Infants predominately breastfed with maternal intent to continue exclusive breastfeeding for at least 9 additional weeks
  • Term infants born \>37 weeks gestation
  • Healthy infants without medical complications
  • Generally healthy women
  • Mothers who are willing to refrain from feeding their infants infant formula, solid foods, and probiotic or iron supplements (confounding variables of the intestinal microbiome) before the end of the study

You may not qualify if:

  • Mothers diagnosed with any metabolic, endocrine, liver, or kidney disease, any autoimmune disease, cirrhosis, hepatitis C, HIV, AIDs, cancer, obesity (pre-pregnancy BMI \>34.9 kg/m2), Crohn's disease, heart disease, type 1 or type 2 diabetes (type 1 diabetes is acceptable if mother's blood glucose has been well-regulated)
  • Infants born in a multiple birth
  • Infants born with medical complications such as: respiratory distress syndrome or birth defects
  • Infants with any GI tract abnormalities
  • Infants who have taken antibiotics within 4 weeks of enrollment or during the Lead-in Period
  • Infants who have taken iron supplements within 4 weeks of enrollment or during the Lead-in Period
  • Infants who have consumed any infant formula within 4 weeks of enrollment or more than 10 times between birth and enrollment or during the Lead-in Period
  • Infants whose parents plan to feed them any infant formula any time throughout the duration of the study
  • Infants who have consumed any probiotics containing B. infantis since birth
  • Infants who have consumed any Bifidobacterium-containing probiotics within 4 weeks of enrollment or during the Lead-in Period
  • Infants whose parents plan to administer probiotics to them any time throughout the duration of the study (not including the study supplement)
  • Infants who have consumed any solid foods or beverages between birth and enrollment or during the Lead-in Period (liquid medicines, supplements, and sugar water are ok)
  • Infants whose parents plan to feed them solid foods or beverages any time throughout the duration of the study
  • Infants whose mothers have changed their minds about their plans to exclusively breastfeed for at least 8 additional weeks by Day 7
  • For infants born vaginally, maternal intake of probiotics containing B. infantis during the last trimester of pregnancy
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Related Publications (1)

  • O'Brien CE, Frese SA, Cernioglo K, Damian-Medina K, Mitchell RD, Casaburi G, Melnyk RA, Henrick BM, Smilowitz JT. Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants' gut microbiome. mSphere. 2025 Dec 22:e0051825. doi: 10.1128/msphere.00518-25. Online ahead of print.

    PMID: 41427732DERIVED

MeSH Terms

Interventions

Lactose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Jennifer Smilowitz, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators and data evaluators will be blinded to the treatment assignments.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Subjects will be enrolled and randomized 1:1:1:1 to the following treatment arms (daily dose of B. infantis EVC001): high dose, medium dose, low dose, and placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

April 6, 2018

Primary Completion

April 3, 2019

Study Completion

April 3, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)