- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994315
The EFFECT Study: Probiotic and HMO Supplementation in Infants (EFFECT)
July 7, 2020 updated by: Evolve BioSystems, Inc.
Exclusively Formula-Fed Infants Effectively Colonizing With B. Infantis EVC001 From Lacto-N-Tetraose Supplementation
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk.
HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial bacteria (bifidobacteria, in particular) in the infant gut.
Exclusively formula-fed infants lack HMOs in their diet in the absence of naturally occurring HMOs from breast milk.
The proposed clinical study will evaluate the ability of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B.
infantis EVC001) in exclusively formula-fed infants.
B. infantis EVC001 has been shown to be well-tolerated and safely consumed in breastfed infants.
This study also aims to evaluate the safety and tolerability of LNT in different doses when consumed daily with B. infantis EVC001.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, prospective, randomized, open-label study of an infant probiotic (B. infantis EVC001) and a prebiotic supplement (LNT) in exclusively formula-fed infants. Nine subjects will be enrolled into three treatment arms:
- Group 1: 8 x 10^9 CFU B. infantis + LNT (3 g/L then 8 g/L)
- Group 2: 8 x 10^9 CFU B. infantis + LNT (6 g/L then 12 g/L)
- Group 3: 8 x 10^9 CFU B. infantis alone Study staff will be unblinded to the treatment assignments. Infants in all groups will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10^9 CFU) mixed with infant formula for 28 consecutive days. Two of the treatment groups (Group 1 & Group 2) will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their daily infant formula: Group 1 will receive a concentration of 3 g/L for 2 weeks followed by 8 g/L for the next 2 weeks. Group 2 will receive a concentration of 6 g/L for 2 weeks followed by 12 g/L for the next 2 weeks. Infants consuming the LNT will cross over to the higher dose without a washout period in between. All infants will be evaluated for an additional 2 weeks after cessation of the supplement(s). The total duration of the study will be approximately 7 weeks.
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
South Carolina
-
Charleston, South Carolina, United States, 29414
- Coastal Pediatric Research
-
-
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
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infant is between 0 and 60 days of life at the time of enrollment
- Infant is exclusively formula-fed with caregiver intent to continue exclusive formula feeding for the duration of the study (at least 7 weeks)
- Infant is consuming cow's milk-based formula without probiotics
- Term infant, born >37 weeks gestation
- Infant is healthy and without medical complications
- Infant's caregivers are willing to refrain from feeding their infant breast milk, solid foods, and non-study probiotics prior to study completion
Exclusion Criteria:
- Infant was born with medical complications such as respiratory distress syndrome or birth defects
- Infant has any gastrointestinal tract abnormalities
- Infant has been diagnosed with failure to thrive
- Infant has taken oral or IV antibiotics or antifungals within 4 weeks of enrollment or during the Lead-in Period
- Infant is consuming partially hydrolyzed or extensively hydrolyzed infant formula because of gastrointestinal disturbance or gassiness/fussiness
- Infant has consumed any breast milk within 7 days of enrollment or during the Lead-in Period
- Infant has consumed any probiotics containing B. infantis since birth
- Infant has consumed any Bifidobacterium-containing probiotics within 2 weeks of enrollment or during the Lead-in Period
- Infant's caregivers plan to feed them any breast milk, solid foods, or non-study probiotics at any time throughout the duration of the study
- Infant was born in a multiple birth
- Infant lives in more than one location
- Any infant who the investigator feels is not an appropriate study participant
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B. infantis EVC001 + LNT (3 g/L then 8 g/L)
Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10^9 CFU) mixed with infant formula for 28 consecutive days.
Group 1 [B.
infantis + LNT (3 g/L then 8 g/L)] will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their infant formula for every formula preparation during the 28-day supplementation period.
They will receive a concentration of 3 g/L for 2 weeks followed by 8 g/L for the next 2 weeks, without a washout period in between.
|
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Other Names:
LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.
|
Experimental: B. infantis EVC001 + LNT (6 g/L then 12 g/L)
Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10^9 CFU) mixed with infant formula for 28 consecutive days.
Group 2 [B.
infantis + LNT (6 g/L then 12 g/L)] will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their infant formula for every formula preparation during the 28-day supplementation period.
They will receive a concentration of 6 g/L for 2 weeks followed by 12 g/L for the next 2 weeks, without a washout period in between.
|
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Other Names:
LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.
|
Active Comparator: B. infantis EVC001 alone
Infants will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10^9 CFU) mixed with infant formula for 28 consecutive days.
|
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
B. infantis levels in infant stool
Time Frame: Baseline, Days 1-35, Day 40
|
To evaluate the ability of different doses of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B.
infantis EVC001) in exclusively formula-fed infants.
DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.
|
Baseline, Days 1-35, Day 40
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total infant gut microbiome modulation
Time Frame: Baseline, Days 5, 12, 19, 26, 40
|
To evaluate the total gut microbiome modulation from supplementation of B. infantis with and without a prebiotic supplement (LNT) in exclusively formula-fed infants.
DNA and RNA will be extracted from stool swab samples and will be used for next generation sequencing to determine relative abundance of the most abundant bacterial taxa.
|
Baseline, Days 5, 12, 19, 26, 40
|
Frequency of adverse events
Time Frame: During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)
|
Frequency of treatment emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
|
During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)
|
Frequency of gastrointestinal symptoms warranting a doctor's visit
Time Frame: During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)
|
Frequency of gastrointestinal symptoms warranting a doctor's visit will be provided by treatment group.
|
During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)
|
Frequency of adverse events resulting in withholding or discontinuing the study products
Time Frame: During supplementation (Day 1 to Day 28)
|
Frequency of adverse events resulting in withholding or discontinuing the study products will be provided by treatment group.
|
During supplementation (Day 1 to Day 28)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rimon Youssef, MD, Coastal Pediatric Research
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)
September 12, 2019
Primary Completion (Actual)
March 13, 2020
Study Completion (Actual)
March 13, 2020
Study Registration Dates
First Submitted
June 19, 2019
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- EV-8901
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.
Clinical Trials on Infant Gut Microbiome
-
Chr HansenAarhus University HospitalCompletedInfant Development | Gut MicrobiomeDenmark
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Colorado... and other collaboratorsCompletedInfant Growth | Infant Gut Microbiome | Infant Body FatUnited States
-
University of AarhusAarhus University Hospital; University of Copenhagen; Arla FoodsActive, not recruitingBreast Milk Collection | Infant Gut Microbiome | Human Milk/Breastfeeding | Human Milk MicrobiomeDenmark
-
University of California, DavisCompletedGut Microbiome | Skin Microbiome | Gut Lipidome | Skin Lipidome | Blood LipidomeUnited States
-
ProgenaBiomeRecruitingGastrointestinal Microbiome | Gut MicrobiomeUnited States
-
University College CorkAIT Austrian Institute of Technology GmbHNot yet recruiting
-
Evolve BioSystems, Inc.University of California, DavisCompletedGut MicrobiomeUnited States
-
State University of New York at BuffaloCompleted
-
Access Business GroupCompletedGut MicrobiomeUnited States
Clinical Trials on B. infantis EVC001
-
Evolve BioSystems, Inc.University of California, DavisCompletedGut MicrobiomeUnited States
-
Evolve BioSystems, Inc.TerminatedInfantile ColicUnited States
-
Alimentary Health LtdWhately-Smith Ltd, King's Langley,UKCompleted
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedFecal Microflora in the Formula Fed Premature InfantUnited States
-
University of Cape TownEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingVaccine Reaction | Hiv | Microbial Colonization | Infant DevelopmentSouth Africa
-
Procter and GambleCompletedBloating | Abdominal DiscomfortUnited States
-
Prolacta BioscienceRecruiting
-
University of California, DavisEvolve BioSystems, Inc.Withdrawn
-
Helmholtz Zentrum MünchenUniversitaire Ziekenhuizen KU Leuven; Technical University of Munich; Medical... and other collaboratorsRecruitingDiabetes Mellitus, Type 1Belgium, Germany, Poland, Sweden, United Kingdom