Infant, NewbornPhase 2NCT00705562
Tolerance of Healthy Term Infants Fed Infant Formulas
A Phase 2 study testing milk protein formulas, varying carbohydrate/protein sources in people with Infant, Newborn, run by Abbott Nutrition at 15 sites in United States.
Trial summary
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- milk protein formulas, varying carbohydrate/protein sources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2008to Dec 2008
- Phase
- Phase 2
- 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 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age
Who cannot join
- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Global Clinical Investigation
Aventura, Florida, 33180
University of Maryland
Baltimore, Maryland, 21201
Kentucky Pediatric Research
Bardstown, Kentucky, 40004
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Iowa
Coralville, Iowa, 52241
Medical Associates Clinic
Dubuque, Iowa, 52002
Pediatric Associates of Fairfield
Fairfield, Ohio, 45014
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68504
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
West Virginia University
Morgantown, West Virginia, 26506
The Center for Human Nutrition
Omaha, Nebraska, 68105
PediaResearch, Inc
Owensboro, Kentucky, 42301
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241
University of South Florida
Tampa, Florida, 33606
About this study
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Conditions
- Infant, Newborn
- Being tested
- milk protein formulas, varying carbohydrate/protein sources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk protein formulas, varying carbohydrate/protein sourcesOther
ad lib for 0-8 days of age until 28 days of age
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental milk protein based infant formula with varying carbohydrate and protein source Receives: Other: milk protein formulas, varying carbohydrate/protein sources |
| 2 | Experimental | Experimental milk protein based infant formula with varying carbohydrate and protein source Receives: Other: milk protein formulas, varying carbohydrate/protein sources |
| 3 | Experimental | Experimental milk protein based infant formula with varying carbohydrate and protein source Receives: Other: milk protein formulas, varying carbohydrate/protein sources |
| 4 | Experimental | Experimental milk protein based infant formula with varying carbohydrate and protein source Receives: Other: milk protein formulas, varying carbohydrate/protein sources |
| 5 | Experimental | Experimental milk protein based infant formula with varying carbohydrate and protein source Receives: Other: milk protein formulas, varying carbohydrate/protein sources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Measured: 0-8 days of age until 28 days of age
Secondary outcomes (1)
GI and intake parameters
Measured: 0-8 to 28 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 posted26 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Davis, PhD, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705562
- Sponsor's protocol ID
- AK62
- Status last verified
- Jan 2009
- First submitted
- 24 Jun 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Healthy Term Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT00705562
- Acronym / sponsor ID
- AK62
- Conditions
- Infant, Newborn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Jun 2008 (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.
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: milk protein formulas, varying carbohydrate/protein sourcesExperimental milk protein based infant formula with varying carbohydrate and protein source |
| 2 | Experimental | Other: milk protein formulas, varying carbohydrate/protein sourcesExperimental milk protein based infant formula with varying carbohydrate and protein source |
| 3 | Experimental | Other: milk protein formulas, varying carbohydrate/protein sourcesExperimental milk protein based infant formula with varying carbohydrate and protein source |
| 4 | Experimental | Other: milk protein formulas, varying carbohydrate/protein sourcesExperimental milk protein based infant formula with varying carbohydrate and protein source |
| 5 | Experimental | Other: milk protein formulas, varying carbohydrate/protein sourcesExperimental milk protein based infant formula with varying carbohydrate and protein source |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age
Key exclusion criteria (1 listed)
- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
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 |
|---|---|---|
| milk protein formulas, varying carbohydrate/protein sourcesad lib for 0-8 days of age until 28 days of age | Other | 1, 2, 3, 4, 5 |
Primary outcome
Gastrointestinal tolerance
Time frame: 0-8 days of age until 28 days of age
1 secondary outcome
GI and intake parameters
Time frame: 0-8 to 28 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 5 Jan 2009.
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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.
Steven Davis, PhD study director
Abbott Nutrition
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing milk protein formulas, varying carbohydrate/protein sources in people with Infant, Newborn, run by Abbott Nutrition at 15 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 1 inclusion and 1 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 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gastrointestinal tolerance (time frame: 0-8 days of age until 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 5 Jan 2009.