Growth of Infants2-FLNCT03109223
Addition to Infant Formula of 2-fucosyllactose (2-FL)
A study testing sole source nutrition in people with Growth of Infants, run by PBM Nutritionals at 6 sites in 2 countries.
Trial summary
OBJECTIVES: Primary: The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same… Read more about this study
- Who is it for?
- Ages 4 to 36 daysHealthy volunteers can take part
- Conditions the study is for
- Growth of Infants
- What is being tested?
- sole source nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Jul 2017to 17 May 2021
- 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 4 to 36 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. At birth:
- Healthy, term (37-42 weeks), appropriate for gestational age 2. At the time of enrollment:
- < 14 days post-natal age at time of enrollment, either gender
- Exclusively formula fed or breastfed upon enrollment Subject must be in general good health and free from any clinically significant disease, condition, or illness that might interfere with the study evaluations. Prior labs must be present to confirm good health.
- Formula group infants: Mother has determined to use infant formula exclusively for feeding her baby through at least 16 weeks.
- Reference breastfed infants: Mother has determined to breastfeed exclusively through at least 16 weeks Written informed consent of parent/guardian, prior to any study related procedures being performed.
Who cannot join
- 1. Any clinically significant abnormal findings, as determined by the investigator, on the subject's medical history or physical exam during screening.
- 2. Use of systemic medications by the subject that in the Investigator's opinion could impact evaluation of the subject's assessments.
- 3. Discontinuation of exclusive breastfeeding by reference group (breastfed) infants.
- 4. Fed with baby/solid foods on average more than once per day.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35205
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Qualmedica Research, LLC dba Pedia Research, LLC
Evansville, Indiana, 47715
JBR Clinical Research
Salt Lake City, Utah, 84107
Advantage Clinical Trials
The Bronx, New York, 10468
About this study
Official title: Effects of Addition to Infant Formula of 2-fucosyllactose (2-FL) on Growth, Fecal Bacterial Populations and Safety
OBJECTIVES:
Primary:
The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same formula containing the human milk oligosaccharide (Test (HMO) 2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently enrolled reference group of exclusively breastfed infants.
Read the detailed description
METHODOLOGY/ STUDY DESIGN: This study is double blinded-randomized controlled trial with two arms and a reference breast fed group. The experimental variable is the composition of infant formula fed to healthy term infants for a period of 16 weeks upon entering the study as their sole source of nutrition. The formulations are a commercial control (Control, NPS-E23); and the control formula containing the human milk oligosaccharide (HMO) 2-fucosyllactose (2FL) at 1g/L (HMO, NPS-E23XA).
Infants will be enrolled on or before 14 days of age and fed a study assigned formula for 16 weeks. Weight, length and head circumference will be measured at baseline and 2, 4, 6, 8, 12 and 16 weeks of study entry. Formula volume will be recorded for a three-day period before each visit. Fecal samples will be obtained at baseline (convenience samples) and at week 16 for all subjects and analyzed for microbial populations. Buccal cheek cells of all infants, and mothers of breast fed infants, obtained by swab at week 16 will be genotyped for FUT2. Information on adverse events and new/change of medications will be collected at in person visits and by telephone interviews between in-person visits.
NUMBER OF SUBJECTS: It is estimated that approximately up to approximately 200 subjects will be enrolled in the formula groups to obtain up to approximately 65 evaluable per protocol subjects in each group. As non-randomized reference group of approximately 85 breastfed infants will be enrolled to obtain approximately 65 evaluable infants.
- Conditions
- Growth of Infants
- Being tested
- sole source nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sole source nutritionOther
Infant formula
| Study group | Role | What they receive |
|---|---|---|
| Commercially availabel infant formula | Active comparator | Not described Receives: Other: sole source nutrition |
| Test formula with 2-FL | Experimental | Not described Receives: Other: sole source nutrition |
| Breast Fed | Active comparator | Not described Receives: Other: sole source nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Growth as compared to WHO Growth Charts
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Jul 2017
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth of InfantsStudies 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
- Double-blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- PBM Nutritionals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109223
- Sponsor's protocol ID
- PRG-VA-17-001
- Acronym
- 2-FL
- Status last verified
- Jun 2021
- First submitted
- 6 Apr 2017
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Addition to Infant Formula of 2-fucosyllactose (2-FL) on Growth, Fecal Bacterial Populations and Safety
- ClinicalTrials.gov ID
- NCT03109223
- Acronym / sponsor ID
- 2-FL / PRG-VA-17-001
- Conditions
- Growth of Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- PBM NutritionalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 12 Apr 2017 (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.
OBJECTIVES:
Primary:
The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same formula containing the human milk oligosaccharide (Test (HMO) 2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently enrolled reference group of exclusively breastfed infants.
Detailed description
METHODOLOGY/ STUDY DESIGN: This study is double blinded-randomized controlled trial with two arms and a reference breast fed group. The experimental variable is the composition of infant formula fed to healthy term infants for a period of 16 weeks upon entering the study as their sole source of nutrition. The formulations are a commercial control (Control, NPS-E23); and the control formula containing the human milk oligosaccharide (HMO) 2-fucosyllactose (2FL) at 1g/L (HMO, NPS-E23XA).
Infants will be enrolled on or before 14 days of age and fed a study assigned formula for 16 weeks. Weight, length and head circumference will be measured at baseline and 2, 4, 6, 8, 12 and 16 weeks of study entry. Formula volume will be recorded for a three-day period before each visit. Fecal samples will be obtained at baseline (convenience samples) and at week 16 for all subjects and analyzed for microbial populations. Buccal cheek cells of all infants, and mothers of breast fed infants, obtained by swab at week 16 will be genotyped for FUT2. Information on adverse events and new/change of medications will be collected at in person visits and by telephone interviews between in-person visits.
NUMBER OF SUBJECTS: It is estimated that approximately up to approximately 200 subjects will be enrolled in the formula groups to obtain up to approximately 65 evaluable per protocol subjects in each group. As non-randomized reference group of approximately 85 breastfed infants will be enrolled to obtain approximately 65 evaluable infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind randomized
| Arm | Type | Receives |
|---|---|---|
| Commercially availabel infant formula | Active comparator | Other: sole source nutrition |
| Test formula with 2-FL | Experimental | Other: sole source nutrition |
| Breast Fed | Active comparator | Other: sole source nutrition |
Who may qualify
- Ages
- 4 to 36 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 1. At birth:
Key exclusion criteria (4 listed)
- 1. Any clinically significant abnormal findings, as determined by the investigator, on the subject's medical history or physical exam during screening.
- 2. Use of systemic medications by the subject that in the Investigator's opinion could impact evaluation of the subject's assessments.
- 3. Discontinuation of exclusive breastfeeding by reference group (breastfed) infants.
- 4. Fed with baby/solid foods on average more than once per day.
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 |
|---|---|---|
| sole source nutritionInfant formula | Other | Breast Fed, Commercially availabel infant formula, Test formula with 2-FL |
Primary outcome
Growth
Time frame: 4 months
Growth as compared to WHO Growth Charts
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 24 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sole source nutrition in people with Growth of Infants, run by PBM Nutritionals at 6 sites in 2 countries.
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 4 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Honduras. 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?
Growth (time frame: 4 months). 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 24 Jun 2021.