ToleranceNCT04529759
Healthy Term Infants Fed Milk-Based Infant Formula
A study testing Experimental Infant Formula in people with Tolerance, run by Abbott Nutrition at 6 sites in United States.
Trial summary
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein 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
- Tolerance
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Sep 2020to 18 Jun 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Good health as determined from participant's medical history
- Singleton from a full-term birth with a gestational age of 37-42 weeks
- Birth weight was > 2490 g (~5 lbs. 8 oz.)
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
- Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other 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 (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Participant is enrolled in another study that has not been approved as a concomitant study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116
Institute of Clinical Research
Mentor, Ohio, 44060
Springs Medical Research
Owensboro, Kentucky, 43203
PAS Research, LLC
Tampa, Florida, 33613
Visions Clinical Research
Tucson, Arizona, 85712
The Cleveland Pediatric Research Center, LLC
Westlake, Ohio, 44145
About this study
Official title: Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.
- Conditions
- 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
Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide
Experimental Infant FormulaOther
Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend
| Study group | Role | What they receive |
|---|---|---|
| Control Infant Formula | Active comparator | Feed ad libitum Receives: Other: Control Infant Formula |
| Experimental Infant Formula | Experimental | Feed ad libitum Receives: Other: Experimental Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rank stool consistency (MRSC)
Parent Completed Diary
Measured: Study Day 1 to 28 Days of Age
Secondary outcomes (4)
Weight
Interval weight gain per day
Measured: 14 to 119 Days of Age
Gastrointestinal tolerance
Parent Completed Diary
Measured: 14 to 119 Days of Age
Length
Interval length gain per day
Measured: 14 to 119 Days of Age
Head Circumference
Interval head circumference gain per day
Measured: 14 to 119 Days of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start12 Sep 2020
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lasekan, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529759
- Sponsor's protocol ID
- AL39
- Status last verified
- Jul 2021
- First submitted
- 25 Aug 2020
- Last updated
- 15 Jul 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
- ClinicalTrials.gov ID
- NCT04529759
- Acronym / sponsor ID
- AL39
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 28 Aug 2020 (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, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Infant Formula | Active comparator | Other: Control Infant FormulaFeed ad libitum |
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaFeed ad libitum |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Good health as determined from participant's medical history
- Singleton from a full-term birth with a gestational age of 37-42 weeks
- Birth weight was > 2490 g (~5 lbs. 8 oz.)
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of 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 (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Participant is enrolled 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 FormulaPowdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide | Other | Control Infant Formula |
| Experimental Infant FormulaPowdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend | Other | Experimental Infant Formula |
Primary outcome
Mean rank stool consistency (MRSC)
Time frame: Study Day 1 to 28 Days of Age
Parent Completed Diary
4 secondary outcomes
Weight
Time frame: 14 to 119 Days of Age
Gastrointestinal tolerance
Time frame: 14 to 119 Days of Age
Length
Time frame: 14 to 119 Days of Age
Head Circumference
Time frame: 14 to 119 Days of Age
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 15 Jul 2021.
- 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.
John Lasekan, PhD study chair
Abbott Nutrition
6 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 Tolerance, run by Abbott Nutrition at 6 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 6 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 15 Jul 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. 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?
Mean rank stool consistency (MRSC) (time frame: Study Day 1 to 28 Days of Age). 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 15 Jul 2021.