- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476447
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants (REMEDI)
April 17, 2019 updated by: Evolve BioSystems, Inc.
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants (The REMEDI Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California, Davis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 4 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Mother-infant dyads who live in more than one location
- Infants who have been diagnosed with any medical or nutritional condition that would require iron supplementation
- Mothers who smoked cigarettes during pregnancy, currently smoke, or plan to initiate smoking during the study duration
- Anyone the investigator feels isn't an applicable subject
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High dose B. infantis EVC001
10 participants will receive powdered B. infantis EVC001 at a high dose per daily oral feeding
|
A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.
|
Active Comparator: Medium dose B. infantis EVC001
10 participants will receive powdered B. infantis EVC001 at a medium dose per daily oral feeding
|
A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.
|
Active Comparator: Low dose B. infantis EVC001
10 participants will receive powdered B. infantis EVC001 at a low dose per daily oral feeding
|
A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.
|
Placebo Comparator: Lactose Placebo
10 participants will receive powdered lactose per daily oral feeding
|
A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal B. infantis levels in infants at 28 days - difference between B. infantis and placebo
Time Frame: 28 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal B. infantis levels in infants at 28 days - difference between B. infantis doses
Time Frame: 28 days
|
The differences between B. infantis EVC001 doses on levels of infant fecal B. infantis (as measured by B. infantis qPCR) on Day 28.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2018
Primary Completion (Actual)
April 3, 2019
Study Completion (Actual)
April 3, 2019
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Actual)
April 19, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1166403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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