Dietary InterventionNCT01079208
Growth of Infants Fed New Starter Formula
A study testing test starter infant formula and test starter infant formula with synbiotics in people with Dietary Intervention, run by Société des Produits Nestlé (SPN) at 3 sites in United States.
Trial summary
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life. Read more about this study
- Who is it for?
- Ages 11 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Dietary Intervention
- What is being tested?
- test starter infant formula and test starter infant formula with synbiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Oct 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 11 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full-term (> 37 weeks gestation)
- Birth weight > 2500 and < 4500 g
- 14±3 days of age on enrollment
- Singleton birth
- Infant's mother has elected not to breastfeed prior to enrollment
- Has not received solid foods
- Having obtained his/her legal representative's informed consent
Who cannot join
- Known or suspected cow-milk allergy
- Congenital illness or malformation that may affect infant feeding and/or growth
- Significant prenatal and/or postnatal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- Has received oral or intravenous antibiotic therapy in the last 7 days
Show all 9Show fewer
- Has received probiotics in the last 7 days
- Currently participating in another clinical study
- Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504
Florida Institute for Clinical Research
Orlando, Florida, 32822
UCSF Institute for Health Policy Studies/Pediatrics
San Francisco, California, 94118
About this study
Official title: Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
Read the detailed description
Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.
The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.
- Conditions
- Dietary Intervention
- Being tested
- test starter infant formula, test starter infant formula with synbiotics, control standard formula
- Keywords
- infant formula, synbiotics, probiotics, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test starter infant formulaOther
infants are fed for 6 months with this starter formula
test starter infant formula with synbioticsOther
infant are fed for 6 months with this formula
control standard formulaOther
infant are fed 6 months with this formula
| Study group | Role | What they receive |
|---|---|---|
| standard starter infant formula | Placebo comparator | standard starter infant formula Receives: Other: control standard formula |
| test starter formula | Experimental | test infant formula Receives: Other: test starter infant formula |
| test starter formula with synbiotics | Experimental | starter formula with synbiotics and adapted protein levels Receives: Other: test starter infant formula with synbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)
Measured: 4 months
Secondary outcomes (1)
Tolerance, morbidity, protein status, metabolic markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary InterventionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Cabana, MD, MPH, Principal investigator, Institute for Health Policy Studies, University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079208
- Sponsor's protocol ID
- 09.04.INF
- Status last verified
- Oct 2013
- First submitted
- 2 Mar 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics
- ClinicalTrials.gov ID
- NCT01079208
- Acronym / sponsor ID
- 09.04.INF
- Conditions
- Dietary Intervention
- Keywords
- infant formula, synbiotics, probiotics, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Mar 2010 (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 purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
Detailed description
Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.
The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.
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 |
|---|---|---|
| standard starter infant formula | Placebo comparator | Other: control standard formulastandard starter infant formula |
| test starter formula | Experimental | Other: test starter infant formulatest infant formula |
| test starter formula with synbiotics | Experimental | Other: test starter infant formula with synbioticsstarter formula with synbiotics and adapted protein levels |
Who may qualify
- Ages
- 11 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy newborn infant
- Full-term (> 37 weeks gestation)
- Birth weight > 2500 and < 4500 g
- 14±3 days of age on enrollment
- Singleton birth
Key exclusion criteria (9 listed)
- Known or suspected cow-milk allergy
- Congenital illness or malformation that may affect infant feeding and/or growth
- Significant prenatal and/or postnatal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
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 |
|---|---|---|
| test starter infant formulainfants are fed for 6 months with this starter formula | Other | test starter formula |
| test starter infant formula with synbioticsinfant are fed for 6 months with this formula | Other | test starter formula with synbiotics |
| control standard formulainfant are fed 6 months with this formula | Other | standard starter infant formula |
Primary outcome
Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)
Time frame: 4 months
1 secondary outcome
Tolerance, morbidity, protein status, metabolic markers
Time frame: 6 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 3 Dec 2014.
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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.
Michael Cabana, MD, MPH principal investigator
Institute for Health Policy Studies, University of California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test starter infant formula and test starter infant formula with synbiotics in people with Dietary Intervention, run by Société des Produits Nestlé (SPN) at 3 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 8 inclusion and 9 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) (time frame: 4 months). 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 3 Dec 2014.