Growth and ToleranceNCT04105686
Growth and Tolerance of Young Infants Fed Infant Formula
A study testing Experimental Infant Formula in people with Growth and Tolerance, run by Abbott Nutrition at 32 sites in United States.
Trial summary
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth and Tolerance
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 32 sitesUnited States
- Study dates
- 30 Sep 2019to 4 Dec 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is judged to be in good health as determined from participant's medical history.
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- Participant's birth weight was > 2490 g (~5 lbs. 8 oz.).
- Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
- Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
- Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
- Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
TOPAZ Clinical Research, Inc.
Apopka, Florida, 32703
Meridian Clinical Research 3080
Baton Rouge, Louisiana, 70806
Gadolin Research, LLC
Beaumont, Texas, 77702
Central Research Associates
Birmingham, Alabama, 35205
Tekton Research
Chamblee, Georgia, 30341
ClinOhio Research Services
Columbus, Ohio, 43213
Ohio Pediatric Research Association
Dayton, Ohio, 45414
PriMed Clinical Research
Dayton, Ohio, 45419
University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics
DeLand, Florida, 32720
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Women's Hospital at Renaissance - Doctors Hospital at Renaissance
Edinburg, Texas, 78539
Deaconess Clinic, Inc.
Evansville, Indiana, 47725
Mercury Clincial Research, Inc.
Houston, Texas, 77008
Children's Research, LLC
Lake Mary, Florida, 32746
Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
DCOL Center for Clinical Research
Longview, Texas, 75605
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116
Medical Research Center of Memphis
Memphis, Tennessee, 38120
Institute of Clinical Research, LLC
Mentor, Ohio, 44060
New Horizon Research Center
Miami, Florida, 33165
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
Saltzer Health
Nampa, Idaho, 83686
Meridan Clinical Research
Omaha, Nebraska, 68134
Aspen Clinical Research LLC
Orem, Utah, 84058
Pediatric & Adult Research Center
Orlando, Florida, 32825
Springs Medical Research
Owensboro, Kentucky, 42303
Asclepes Research Centers
Spring Hill, Florida, 34609
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
PAS Research, LLC
Tampa, Florida, 33613
Visions Clinical Research
Tucson, Arizona, 85712
About this study
Official title: Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
- Conditions
- Growth and Tolerance
- Being tested
- Control Infant Formula, Experimental Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Infant FormulaOther
Ready to feed infant formula, feed ad libitum
Experimental Infant FormulaOther
Ready to feed infant formula, feed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Control Infant Formula | Active comparator | Milk-based study product Receives: Other: Control Infant Formula |
| Experimental Infant Formula | Experimental | Milk-based study product with oligosaccharides Receives: Other: Experimental Infant Formula |
| Reference Group | No intervention | Human milk-fed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight gain per day
Measured: Day of life 14 to Day of life 119
Secondary outcomes (4)
Stool Characteristics
Parent completed diary
Measured: Study Day 1 to Day of life 119
Formula Tolerance
Parent completed diary
Measured: Study Day 1 to Day of life 119
Length
Length gain per day
Measured: Day of life 14 to Day of life 119
Head Circumference (HC)
HC gain per day
Measured: Day of life 14 to Day of life 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Sep 2019
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth and ToleranceStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timberly Williams, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105686
- Sponsor's protocol ID
- AL31A
- Status last verified
- Jan 2021
- First submitted
- 25 Sep 2019
- Last updated
- 25 Jan 2021
- 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
- ClinicalTrials.gov ID
- NCT04105686
- Acronym / sponsor ID
- AL31A
- Conditions
- Growth and Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 26 Sep 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.
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Infant Formula | Active comparator | Other: Control Infant FormulaMilk-based study product |
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaMilk-based study product with oligosaccharides |
| Reference Group | No intervention | –Human milk-fed group |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Participant is judged to be in good health as determined from participant's medical history.
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- Participant's birth weight was > 2490 g (~5 lbs. 8 oz.).
- Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
- Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study.
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 |
|---|---|---|
| Control Infant FormulaReady to feed infant formula, feed ad libitum | Other | Control Infant Formula |
| Experimental Infant FormulaReady to feed infant formula, feed ad libitum | Other | Experimental Infant Formula |
Primary outcome
Weight
Time frame: Day of life 14 to Day of life 119
Weight gain per day
4 secondary outcomes
Stool Characteristics
Time frame: Study Day 1 to Day of life 119
Formula Tolerance
Time frame: Study Day 1 to Day of life 119
Length
Time frame: Day of life 14 to Day of life 119
Head Circumference (HC)
Time frame: Day of life 14 to Day of life 119
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 25 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Growth and Tolerance
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements
Healthy Infants
Not yet recruitingObservational study
Growth Hormone Resistance of Beta-cells
Healthy, Obesity & Overweight
Not yet recruiting
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
Cow Milk Protein Allergy, FPIES
Not yet recruiting
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Faltering Growth, Failure to Thrive
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.
Timberly Williams, PhD study chair
Abbott Nutrition
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula in people with Growth and Tolerance, run by Abbott Nutrition at 32 sites 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 8 inclusion and 3 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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?
Weight (time frame: Day of life 14 to Day of life 119). 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 25 Jan 2021.