Infant Gut MicrobiomeEFFECTNCT03994315
The EFFECT Study: Probiotic and HMO Supplementation in Infants
A study testing B. infantis EVC001 and Lacto-N-tetraose (LNT) in people with Infant Gut Microbiome, run by Evolve BioSystems, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Gut Microbiome
- What is being tested?
- B. infantis EVC001 and Lacto-N-tetraose (LNT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 13 Mar 2020
- 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 Up to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Pediatric Research
Charleston, South Carolina, 29414
About this study
Official title: 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.
Read the 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.
- Conditions
- Infant Gut Microbiome
- Being tested
- B. infantis EVC001, Lacto-N-tetraose (LNT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis EVC001Other
Also called Evivo
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Lacto-N-tetraose (LNT)Other
LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.
| Study group | Role | What they receive |
|---|---|---|
| B. infantis EVC001 + LNT (3 g/L then 8 g/L) | Experimental | 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. Receives: Other: B. infantis EVC001; Other: Lacto-N-tetraose (LNT) |
| B. infantis EVC001 + LNT (6 g/L then 12 g/L) | Experimental | 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. Receives: Other: B. infantis EVC001; Other: Lacto-N-tetraose (LNT) |
| B. infantis EVC001 alone | Active comparator | 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. Receives: Other: B. infantis EVC001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
B. infantis levels in infant stool
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.
Measured: Baseline, Days 1-35, Day 40
Secondary outcomes (4)
Total infant gut microbiome modulation
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.
Measured: Baseline, Days 5, 12, 19, 26, 40
Frequency of adverse events
Frequency of treatment emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
Measured: During supplementation (Day 1 to Day 28) and Post-supplementation (Day 29 to Day 42)
Frequency of gastrointestinal symptoms warranting a doctor's visit
Frequency of gastrointestinal symptoms warranting a doctor's visit will be provided by treatment group.
Measured: 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
Frequency of adverse events resulting in withholding or discontinuing the study products will be provided by treatment group.
Measured: During supplementation (Day 1 to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Sep 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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 randomized (1:1:1) using sealed envelopes into three treatment arms.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve BioSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rimon Youssef, MD, Principal investigator, Coastal Pediatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994315
- Sponsor's protocol ID
- EV-8901
- Acronym
- EFFECT
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusively Formula-Fed Infants Effectively Colonizing With B. Infantis EVC001 From Lacto-N-Tetraose Supplementation
- ClinicalTrials.gov ID
- NCT03994315
- Acronym / sponsor ID
- EFFECT / EV-8901
- Conditions
- Infant Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Evolve BioSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 21 Jun 2019 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model 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 randomized (1:1:1) using sealed envelopes into three treatment arms.
| Arm | Type | Receives |
|---|---|---|
| B. infantis EVC001 + LNT (3 g/L then 8 g/L) | Experimental | Other: B. infantis EVC001, Other: Lacto-N-tetraose (LNT)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. |
| B. infantis EVC001 + LNT (6 g/L then 12 g/L) | Experimental | Other: B. infantis EVC001, Other: Lacto-N-tetraose (LNT)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. |
| B. infantis EVC001 alone | Active comparator | Other: B. infantis EVC001Infants 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. |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 EVC001Also: EvivoBifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU) | Other | B. infantis EVC001 + LNT (3 g/L then 8 g/L), B. infantis EVC001 + LNT (6 g/L then 12 g/L), B. infantis EVC001 alone |
| Lacto-N-tetraose (LNT)LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis. | Other | B. infantis EVC001 + LNT (3 g/L then 8 g/L), B. infantis EVC001 + LNT (6 g/L then 12 g/L) |
Primary outcome
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.
4 secondary outcomes
Total infant gut microbiome modulation
Time frame: 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 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 adverse events resulting in withholding or discontinuing the study products
Time frame: During supplementation (Day 1 to Day 28)
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 9 Jul 2020.
- 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.
Rimon Youssef, MD principal investigator
Coastal Pediatric Research
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 Lacto-N-tetraose (LNT) in people with Infant 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 6 inclusion and 12 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 9 Jul 2020. 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. 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?
B. infantis levels in infant stool (time frame: Baseline, Days 1-35, Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2020.