Growth and ToleranceNCT01808105
Growth and Tolerance of Infants Fed Infant Formulas
A study testing Experimental Formula 1, Experimental Formula 2 and Human Milk in people with Growth and Tolerance, run by Abbott Nutrition at 25 sites in 2 countries.
Trial summary
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk. Read more about this study
- Who is it for?
- Ages Up to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Growth and Tolerance
- What is being tested?
- Experimental Formula 1, Experimental Formula 2 and Human Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Apr 2013to Feb 2014
- 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 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton from full term birth with a gestational age 37-42 weeks
- Birth weight > 2490 g (~5 lbs 8 oz)
- Between 0 and 5 days of age
- Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
- Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
- No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
Who cannot join
- Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- Treatment with antibiotics
- Mother intends to use a combination of breast and formula feeding
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35205
Atlantic Clinical Research Collaborative
Boynton Beach, Florida, 33472
MetroHealth Medical Center
Cleveland, Ohio, 44109
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, 80920
Southeast Regional Research Group (SERRG)
Columbus, Georgia, 31904
Dayton Clinical Research
Dayton, Ohio, 45406
Ohio Pediatric Research Association, Inc
Dayton, Ohio, 45414
Alabama Clinical Therapeutics
Dothan, Alabama, 36305
Clinical Trials of America
Eugene, Oregon, 97401
PediaResearch, LLC
Evansville, Indiana, 47720
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46256
Lafayette Clinical Research
Lafayette, Indiana, 47905
Tanner Memorial Clinic
Layton, Utah, 84041
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Lake Mary Pediatrics
Orange City, Florida, 32763
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114
Sanford Research
Sioux Falls, South Dakota, 65104
Rockwood Clinic, PS
Spokane, Washington, 99202
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
USF, College of Medicine, Dept of Pediatrics
Tampa, Florida, 33606
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, 85712
Puerto Rico2 sites
Clinical Research Puerto Rico
Guayama, 00784
Ponce School of Medicine/ CAIMED Center
Ponce, 00716
About this study
Official title: Growth and Tolerance of Young Infants Fed Infant Formulas
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
- Conditions
- Growth and Tolerance
- Being tested
- Control Formula, Experimental Formula 1, Experimental Formula 2, Human Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control FormulaOther
Also called Commercially available Infant Formula
Feeding ad libitum
Experimental Formula 1Other
Feeding ad libitum
Experimental Formula 2Other
Feeding ad libitum
Human MilkOther
Also called Breast feeding group
Feeding ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Human Milk | Other | Reference group, breast feeding ad libitum Receives: Other: Human Milk |
| Control Formula | Active comparator | Ready to feed infant formula, feed ad libitum Receives: Other: Control Formula |
| Experimental Formula 1 | Experimental | Ready to feed infant formula with human milk oligosaccharides, feed ad libitum Receives: Other: Experimental Formula 1 |
| Experimental Formula 2 | Experimental | Ready to feed infant formula with human milk oligosaccharides, feed ad libitum Receives: Other: Experimental Formula 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight gain per day
Measured: Study Day (SD) 14 - 119
Secondary outcomes (4)
Stool Characteristics
Stool consistency and number per day
Measured: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance
% of feedings with spit up associated with feeding
Measured: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length
Length and interval length gain per day
Measured: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference
Head circumference (HC) and interval HC gain per day
Measured: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808105
- Sponsor's protocol ID
- AL06
- Status last verified
- May 2014
- First submitted
- 7 Mar 2013
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339.
PubMed 37242222Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.
PubMed 27798337
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Young Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT01808105
- Acronym / sponsor ID
- AL06
- Conditions
- Growth and Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Mar 2013 (estimated)
- 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.
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Human Milk | Other | Other: Human MilkReference group, breast feeding ad libitum |
| Control Formula | Active comparator | Other: Control FormulaReady to feed infant formula, feed ad libitum |
| Experimental Formula 1 | Experimental | Other: Experimental Formula 1Ready to feed infant formula with human milk oligosaccharides, feed ad libitum |
| Experimental Formula 2 | Experimental | Other: Experimental Formula 2Ready to feed infant formula with human milk oligosaccharides, feed ad libitum |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Singleton from full term birth with a gestational age 37-42 weeks
- Birth weight > 2490 g (~5 lbs 8 oz)
- Between 0 and 5 days of age
- Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
Key exclusion criteria (4 listed)
- Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- Treatment with antibiotics
- Mother intends to use a combination of breast and formula feeding
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 FormulaAlso: Commercially available Infant FormulaFeeding ad libitum | Other | Control Formula |
| Experimental Formula 1Feeding ad libitum | Other | Experimental Formula 1 |
| Experimental Formula 2Feeding ad libitum | Other | Experimental Formula 2 |
| Human MilkAlso: Breast feeding groupFeeding ad libitum | Other | Human Milk |
Primary outcome
Weight
Time frame: Study Day (SD) 14 - 119
Weight gain per day
4 secondary outcomes
Stool Characteristics
Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance
Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length
Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference
Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
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 2 Jun 2014.
- Derived from this study: PubMed 37242222Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339.
- Derived from this study: PubMed 27798337Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.
Related trials for Growth and Tolerance
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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
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Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
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Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
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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.
Jennifer Williams, MPH study chair
Abbott Nutrition
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Formula 1, Experimental Formula 2 and Human Milk in people with Growth and Tolerance, run by Abbott Nutrition at 25 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 7 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 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Puerto Rico. 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: Study Day (SD) 14 - 119). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808105, which also lists 2 linked publications.
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 2 Jun 2014.