Probiotic Formula and Infant Growth
This study is currently recruiting participants.
Verified November 2011 by Nestlé
Sponsor:
Nestlé
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT01476397
First received: November 14, 2011
Last updated: November 17, 2011
Last verified: November 2011
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Purpose
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
| Condition | Intervention |
|---|---|
|
Healthy |
Other: Control infant formula Other: Test infant formula |
| Study Type: | Interventional |
| Official Title: | ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]weight gain assessed monthly
Secondary Outcome Measures:
- other growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]Length, head circumference will be measured at monthly visits
- adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]all adverse events will be documented throughout the study
- stool characteristics [ Time Frame: throughout study ] [ Designated as safety issue: No ]stool frequency, color, consistency
- spit-up [ Time Frame: throughout study ] [ Designated as safety issue: No ]frequency of spit-up as reported by caregivers
- vomit [ Time Frame: throughout study ] [ Designated as safety issue: No ]frequency of vomitting as reported by caregivers
| Study Start Date: | November 2011 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: control infant formula
partially hydrolyzed whey infant formula
|
Other: Control infant formula
partially hydrolyzed whey infant formula consumed ad libitum throughout study
|
|
Experimental: test infant formula
partially hydrolyzed whey infant formula with probiotic
|
Other: Test infant formula
partially hydrolyzed whey formula with probiotic
|
Eligibility| Ages Eligible for Study: | up to 17 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy newborn infant
- Full-term
- Birth weight > 2500 and < 4500 g
- 14±3 days of age on enrollment
- Exclusively formula-fed, singleton birth
- 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 prior to enrollment
- Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
- Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
- Currently participating in another clinical study
- Cannot be expected to comply with treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476397
Locations
| United States, Arizona | |
| North Scottsdale Pediatric Associates | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Ronald Fischler, MD 480-634-2995 | |
| Principal Investigator: Ronald Fischler, MD | |
| United States, Georgia | |
| Pediatrics & Adolescent Medicine | Recruiting |
| Marietta, Georgia, United States, 30189 | |
| Contact: Wilson Andrews, MD wandrew@pampapediatrics.com | |
| Principal Investigator: Wilson Andrews, MD | |
| United States, Kentucky | |
| Kentucky Pediatric Adult Research | Recruiting |
| Bardstown, Kentucky, United States, 40004 | |
| Contact: James Hedrick, MD 502-349-1569 | |
| Principal Investigator: James Hedrick, MD | |
| United States, North Carolina | |
| PMG Research of Winston-Salem | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Robert Ford, MD 336-768-8062 | |
| Principal Investigator: Robert Ford, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: James Roberts, MD 843-876-0219 | |
| Principal Investigator: James Roberts, MD | |
| United States, Tennessee | |
| PMG Research of Bristol | Recruiting |
| Bristol, Tennessee, United States, 37620 | |
| Contact: Bernard Grunstra, MD 423-989-3105 | |
| Principal Investigator: Bernard Grunstra, MD | |
| United States, Texas | |
| Pediatric Healthcare of Northwest Houston | Recruiting |
| Tomball, Texas, United States, 77375 | |
| Contact: Khozema Palanpurwala, MD 281-517-0550 | |
| Principal Investigator: Khozema Palanpurwala, MD | |
| United States, Virginia | |
| Advanced Pediatrics | Recruiting |
| Vienna, Virginia, United States, 22180 | |
| Contact: Richard Schwartz, MD 703-938-5555 | |
| Principal Investigator: Richard Schwartz, MD | |
Sponsors and Collaborators
Nestlé
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01476397 History of Changes |
| Other Study ID Numbers: | 10.01.US.INF |
| Study First Received: | November 14, 2011 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nestlé:
|
full-term formula-fed infants |
ClinicalTrials.gov processed this record on June 18, 2013