HealthyPhase 2/3NCT00543673
Tolerance of Healthy, Term Infants to Infant Formulas
A Phase 2/3 study testing Milk based formula A, #2 Standard formula and #3 Human Milk in people with Healthy, run by Abbott Nutrition at 10 sites in United States.
Trial summary
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milk based formula A, #2 Standard formula and #3 Human Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2007to Jun 2008
- 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
- judged to be in good health.
- singleton from a full term birth with a gestational age of 37-42 weeks
- birth weight was > 2490 g (~5 lbs 8 oz)
- between 0 and 8 days of age at enrollment.
- Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) 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 infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
- Infant has been treated with antibiotics.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Levine Childrens Hospital
Charlotte, North Carolina, 28207
North Georgia Clinical Research, White's Pediatrics
Dalton, Georgia, 30721
Medical Associates Clinic
Dubuque, Iowa, 52001
Ohio Pediatrics, Inc.
Huber Heights, Ohio, 45424
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68505
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
The Pediatric Clinic
North Little Rock, Arkansas, 72117
The Childrens Medical Group LLC
Poughkeepsie, New York, 12603
USF
Tampa, Florida, 33606
Scott & White Memorial Hospital
Temple, Texas, 78508
About this study
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
- Conditions
- Healthy
- Being tested
- Milk based formula A, #2 Standard formula, #3 Human Milk, Milk based formula C
- Keywords
- Healthy term infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk based formula AOther
Also called AN0710A
feed as per HCP directions
#2 Standard formulaOther
Also called AN0710B
Feed as per HCP directions
#3 Human MilkOther
Also called Human Milk
Feed as per HCP directions
Milk based formula COther
Also called AN0710C
Feed as per HCP direction
| Study group | Role | What they receive |
|---|---|---|
| Milk based formula A | Experimental | Experimental milk based infant formula Receives: Other: Milk based formula A |
| Standard formula | Active comparator | standard milk based infant formula Receives: Other: #2 Standard formula |
| Reference | Other | Human milk Receives: Other: #3 Human Milk |
| Milk based formula C | Experimental | Experimental milk based infant formula Receives: Other: Milk based formula C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rank stool consistency (MRSC)
Measured: Study Day 1 to Visit 3
Secondary outcomes (1)
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timberly A. Williams, M.S., Study chair, Abbott Nutrition, Abbott Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543673
- Sponsor's protocol ID
- AK53
- Status last verified
- Jun 2008
- First submitted
- 5 Oct 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513.
PubMed 25061716
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Healthy, Term Infants to Infant Formulas
- ClinicalTrials.gov ID
- NCT00543673
- Acronym / sponsor ID
- AK53
- Conditions
- Healthy
- Keywords
- Healthy term infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Oct 2007 (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 assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk based formula A | Experimental | Other: Milk based formula AExperimental milk based infant formula |
| Standard formula | Active comparator | Other: #2 Standard formulastandard milk based infant formula |
| Reference | Other | Other: #3 Human MilkHuman milk |
| Milk based formula C | Experimental | Other: Milk based formula CExperimental milk based infant formula |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- judged to be in good health.
- singleton from a full term birth with a gestational age of 37-42 weeks
- birth weight was > 2490 g (~5 lbs 8 oz)
- between 0 and 8 days of age at enrollment.
- Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Key exclusion criteria (2 listed)
- An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
- Infant has been treated with antibiotics.
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 based formula AAlso: AN0710Afeed as per HCP directions | Other | Milk based formula A |
| #2 Standard formulaAlso: AN0710BFeed as per HCP directions | Other | Standard formula |
| #3 Human MilkAlso: Human MilkFeed as per HCP directions | Other | Reference |
| Milk based formula CAlso: AN0710CFeed as per HCP direction | Other | Milk based formula C |
Primary outcome
Mean rank stool consistency (MRSC)
Time frame: Study Day 1 to Visit 3
1 secondary outcome
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting
Time frame: 4 months
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 4 Jul 2008.
- Derived from this study: PubMed 25061716Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513.
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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 A. Williams, M.S. study chair
Abbott Nutrition, Abbott Laboratories
10 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 Milk based formula A, #2 Standard formula and #3 Human Milk in people with Healthy, run by Abbott Nutrition at 10 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 5 inclusion and 2 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 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Mean rank stool consistency (MRSC) (time frame: Study Day 1 to Visit 3). 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 NCT00543673, which also lists 1 linked publication.
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 4 Jul 2008.