Infant, NewbornPhase 2/3NCT00798382
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
A Phase 2/3 study testing soy protein formula, Commercially available soy formula and Soy formula experimental #2 in people with Infant, Newborn, run by Abbott Nutrition at 17 sites in United States.
Trial summary
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula. 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?
- soy protein formula, Commercially available soy formula and Soy formula experimental #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2008to Sep 2009
- Phase
- Phase 2/3
- 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
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2490 g (~5 lb 8 oz).
- Infant is between 0 and 8 days of age at enrollment.
- 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, solid foods or juices to their infant for the duration of the study.
- Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.
Who cannot join
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics.
- Infant has received probiotics.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Kentucky Pediatric Research
Bardstown, Kentucky, 40004
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, 45245
MetroHealth Medical Center
Cleveland, Ohio, 44109
North Georgia Clinical Research
Dalton, Georgia, 30721
Dayton Clinical Research
Dayton, Ohio, 45406
Medical Associates Clinic
Dubuque, Iowa, 52002
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68504
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Institute of Clinical Research, LLC
Mayfield Heights, Ohio, 44124
West Virginia University, Department of Pediatrics
Morgantown, West Virginia, 26506
Center for Human Nutrition
Omaha, Nebraska, 68105
PediaResearch, LLC
Owensboro, Kentucky, 42301
Primary Physician's Research, Inc
Pittsburgh, Pennsylvania, 15241
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, 33324
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
University of South Florida Health Pediatrics
Tampa, Florida, 33606
About this study
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
- Conditions
- Infant, Newborn
- Being tested
- soy protein formula, Commercially available soy formula, Soy formula experimental #2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy protein formulaOther
Also called experimental soy formula
ad lib for 0-35 days of age
Commercially available soy formulaOther
ad lib for 0-35 days of age
Soy formula experimental #2Other
Also called Experimental soy formula
ad lib for 0-35 days of age
| Study group | Role | What they receive |
|---|---|---|
| 1: Soy formula | Experimental | experimental soy formula #1 Receives: Other: soy protein formula |
| 2: Soy Formula | Active comparator | Commercially available soy formula Receives: Other: Commercially available soy formula |
| 3: Soy formula | Experimental | experimental soy formula #2 Receives: Other: Soy formula experimental #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Measured: 35 days
Secondary outcomes (1)
Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionSep 2009
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 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
- NCT00798382
- Sponsor's protocol ID
- AK54
- Status last verified
- Jun 2012
- First submitted
- 25 Nov 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT00798382
- Acronym / sponsor ID
- AK54
- Conditions
- Infant, Newborn
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Nov 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 this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Soy formula | Experimental | Other: soy protein formulaexperimental soy formula #1 |
| 2: Soy Formula | Active comparator | Other: Commercially available soy formulaCommercially available soy formula |
| 3: Soy formula | Experimental | Other: Soy formula experimental #2experimental soy formula #2 |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2490 g (~5 lb 8 oz).
- Infant is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics.
- Infant has received probiotics.
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 |
|---|---|---|
| soy protein formulaAlso: experimental soy formulaad lib for 0-35 days of age | Other | 1: Soy formula |
| Commercially available soy formulaad lib for 0-35 days of age | Other | 2: Soy Formula |
| Soy formula experimental #2Also: Experimental soy formulaad lib for 0-35 days of age | Other | 3: Soy formula |
Primary outcome
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Time frame: 35 days
1 secondary outcome
Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age
Time frame: 35 days
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 14 Jun 2012.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing soy protein formula, Commercially available soy formula and Soy formula experimental #2 in people with Infant, Newborn, run by Abbott Nutrition at 17 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 from Study Visit 1 to Study Visit 3 at 35 days of age. (time frame: 35 days). 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 14 Jun 2012.