Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

This study is currently recruiting participants.
Verified March 2013 by Arla Foods
Sponsor:
Information provided by (Responsible Party):
Arla Foods
ClinicalTrials.gov Identifier:
NCT01755481
First received: December 12, 2012
Last updated: April 5, 2013
Last verified: March 2013
  Purpose

To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.


Condition Intervention
Focus on Healthy Infants
Other: Probiotic
Other: Whey protein concentrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

Resource links provided by NLM:


Further study details as provided by Arla Foods:

Primary Outcome Measures:
  • Infections episodes (gastrointestinal and upper and lower respiratory infections) [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics F19
F19 in an infant formula
Other: Probiotic
Experimental: Whey protein concentrate
Whey protein concentrate in an infant formula
Other: Whey protein concentrate

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria (formula-fed group):

healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days

Inclusion criteria (breast-fed group):

healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).

Inclusion criteria (all infants):

delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese

Exclusion criteria (formula-fed group):

fully or partially breast-fed infants infants breast-fed >20%

Exclusion criteria (breast-fed group):

infants fed >20% infant formula

Exclusion criteria (all infants):

malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755481

Contacts
Contact: Yongmei Peng, M.D., Ph.D., ympeng99@yahoo.com
Contact: Xiaonan Li, M.D., Ph.D., xiaonan6189@yahoo.com

Locations
China
Department of Child Health Care, Children's Hospital, Fudan University Recruiting
Shanghai, China
Contact: Yongmei Peng, M.D., Ph.D.,       ympeng99@yahoo.com.cn   
Contact: Xiaonan Li, M.D., Ph.D.,       xiaonan6189@yahoo.com   
Sponsors and Collaborators
Arla Foods
Investigators
Principal Investigator: Yongmei Peng, M.D., Ph.D. Children's Hospital, Fudan University, Shanghai, China
  More Information

No publications provided

Responsible Party: Arla Foods
ClinicalTrials.gov Identifier: NCT01755481     History of Changes
Other Study ID Numbers: 327727-2
Study First Received: December 12, 2012
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014