Gut MicrobiomeREMEDINCT03476447
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants
A study testing B. infantis EVC001 and Lactose in people with Gut Microbiome, run by Evolve BioSystems, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- B. infantis EVC001 and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: 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.
Read the 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
- Being tested
- B. infantis EVC001, Lactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
LactoseOther
A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| High dose B. infantis EVC001 | Active comparator | 10 participants will receive powdered B. infantis EVC001 at a high dose per daily oral feeding Receives: 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 Receives: 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 Receives: Other: B. infantis EVC001 |
| Lactose Placebo | Placebo comparator | 10 participants will receive powdered lactose per daily oral feeding Receives: Other: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Fecal B. infantis levels in infants at 28 days - difference between B. infantis doses
The differences between B. infantis EVC001 doses on levels of infant fecal B. infantis (as measured by B. infantis qPCR) on Day 28.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start6 Apr 2018
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve BioSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Jennifer Smilowitz, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476447
- Sponsor's protocol ID
- 1166403
- Acronym
- REMEDI
- Status last verified
- Apr 2019
- First submitted
- 19 Mar 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jan 27;11(1):e0051825. doi: 10.1128/msphere.00518-25. Epub 2025 Dec 22.
PubMed 41427732
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants (The REMEDI Study)
- ClinicalTrials.gov ID
- NCT03476447
- Acronym / sponsor ID
- REMEDI / 1166403
- Conditions
- Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Evolve BioSystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High dose B. infantis EVC001 | Active comparator | Other: B. infantis EVC00110 participants will receive powdered B. infantis EVC001 at a high dose per daily oral feeding |
| Medium dose B. infantis EVC001 | Active comparator | Other: B. infantis EVC00110 participants will receive powdered B. infantis EVC001 at a medium dose per daily oral feeding |
| Low dose B. infantis EVC001 | Active comparator | Other: B. infantis EVC00110 participants will receive powdered B. infantis EVC001 at a low dose per daily oral feeding |
| Lactose Placebo | Placebo comparator | Other: Lactose10 participants will receive powdered lactose per daily oral feeding |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. infantis EVC001A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days. | Other | High dose B. infantis EVC001, Low dose B. infantis EVC001, Medium dose B. infantis EVC001 |
| LactoseA once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days. | Other | Lactose Placebo |
Primary outcome
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.
1 secondary outcome
Fecal B. infantis levels in infants at 28 days - difference between B. infantis doses
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 41427732O'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. 2026 Jan 27;11(1):e0051825. doi: 10.1128/msphere.00518-25. Epub 2025 Dec 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Smilowitz, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. infantis EVC001 and Lactose in people with Gut Microbiome, run by Evolve BioSystems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal B. infantis levels in infants at 28 days - difference between B. infantis and placebo (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.