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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013