Gastro-Intestinal ToleranceNCT03967132
Growth and Tolerance of Infants Fed Milk-Based Infant Formula
A study testing Experimental Infant Formula and Reference Group in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Tolerance
- What is being tested?
- Experimental Infant Formula and Reference Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 19 sitesUnited States
- Study dates
- 8 Jun 2019to 29 May 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
- 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.)
- If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
- If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
- Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study by AN.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726
Deaconess Clinic, Inc.
Evansville, Indiana, 47725
Ventavia Research Group, LLC
Fort Worth, Texas, 76104
Ventavia Research Group
Houston, Texas, 77008
Clinical Research Prime
Idaho Falls, Idaho, 83404
Ventavia Research Group, LLC 3078
Keller, Texas, 76248
Holston Medical Group
Kingsport, Tennessee, 37660
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116
Institute of Clinical Research, LLC
Mentor, Ohio, 44060
Phoenix Medical Research LLC
Miami, Florida, 33165
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, 40356
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360
University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
Orlando, Florida, 32829
Springs Medical Research
Owensboro, Kentucky, 42303
Kagan Pediatrics - HD Research Corporation
Pearland, Texas, 77584
Plano Pediatrics - ACRC Trials
Plano, Texas, 75093
Pediatric Medical Associates
Sacramento, California, 95815
Watching Over Mothers & Babies
Tucson, Arizona, 85712
About this study
Official title: Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
- Conditions
- Gastro-Intestinal Tolerance
- Being tested
- Control Infant Formula, Experimental Infant Formula, Reference Group
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
Reference GroupOther
Human milk, breast feeding ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Control Infant Formula | Active comparator | Milk-based infant formula Receives: Other: Control Infant Formula |
| Experimental Infant Formula | Experimental | Milk-based Infant Formula with oligosaccharides Receives: Other: Experimental Infant Formula |
| Reference Group | Other | Human-milk fed Receives: Other: Reference 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 - 119
Secondary outcomes (5)
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: Study Day 1 to Day of life 119
Head Circumference (HC)
HC gain per day
Measured: Study Day 1 to Day of life 119
Illness Incidence
Parent reported incidence of illness
Measured: Study Day 1 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 posted30 May 2019
- Study start8 Jun 2019
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal 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
- 189 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
- NCT03967132
- Sponsor's protocol ID
- AL29A
- Status last verified
- Sep 2020
- First submitted
- 27 May 2019
- Last updated
- 22 Sep 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 22 Sep 2020. 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
- NCT03967132
- Acronym / sponsor ID
- AL29A
- Conditions
- Gastro-Intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 30 May 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.
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
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 infant formula |
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaMilk-based Infant Formula with oligosaccharides |
| Reference Group | Other | Other: Reference GroupHuman-milk fed |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 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.)
- If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
- If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
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 GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study by AN.
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 |
| Reference GroupHuman milk, breast feeding ad libitum | Other | Reference Group |
Primary outcome
Weight
Time frame: Day of life 14 - 119
Weight gain per day
5 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: Study Day 1 to Day of life 119
Head Circumference (HC)
Time frame: Study Day 1 to Day of life 119
Illness Incidence
Time frame: Study Day 1 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 22 Sep 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.
Timberly Williams, PhD study chair
Abbott Nutrition
19 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 and Reference Group in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 19 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 7 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 - 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 22 Sep 2020.