Growth of Infants Fed New Starter Formula
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dietary Intervention |
Other: test starter infant formula Other: test starter infant formula with synbiotics Other: control standard formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics |
- 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 ] [ Designated as safety issue: Yes ]
- Tolerance, morbidity, protein status, metabolic markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 297 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: standard starter infant formula
standard starter infant formula
|
Other: control standard formula
infant are fed 6 months with this formula
|
|
Experimental: test starter formula
test infant formula
|
Other: test starter infant formula
infants are fed for 6 months with this starter formula
|
|
Experimental: test starter formula with synbiotics
starter formula with synbiotics and adapted protein levels
|
Other: test starter infant formula with synbiotics
infant are fed for 6 months with this formula
|
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.
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Contacts and Locations| Contact: Adebimpe Awolowo Akinsuyi | +19735937730 | adebimpe.awolowoakinsuyi@rd.nestle.com |
| United States, California | |
| UCSF Institute for Health Policy Studies/Pediatrics | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: Michelle McKean 415-476-2860 McKeanM@peds.ucsf.edu | |
| Contact: Michael D Cabana, MD, MPH 415-476-5473 ext 5473 michael.cabana@ucsf.edu | |
| Principal Investigator: Michael D Cabana, MD, MPH | |
| United States, Florida | |
| Florida Institute for Clinical Research | Recruiting |
| Orlando, Florida, United States, 32822 | |
| Contact: Vianica Moraguez 407-658-0966 vmoraguez@ficresearch.com | |
| Contact: Humberto Cruz, DO 407-658-0966 FICResearch@yahoo.com | |
| Principal Investigator: Humberto Cruz, DO | |
| United States, Nebraska | |
| Midwest Children's Health Research Institute | Recruiting |
| Lincoln, Nebraska, United States, 68504 | |
| Contact: Julie Layton 402-327-6065 Julie.Layton@mchri.com | |
| Principal Investigator: Stephen Russell, MD | |
| Principal Investigator: | Michael Cabana, MD, MPH | Institute for Health Policy Studies, University of California |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01079208 History of Changes |
| Other Study ID Numbers: | 09.04.INF |
| Study First Received: | March 2, 2010 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nestlé:
|
infant formula, synbiotics, probiotics, nutrition |
ClinicalTrials.gov processed this record on May 21, 2013