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Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

This study is currently recruiting participants.
Verified January 2017 by Arla Foods
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755481
First Posted: December 24, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Arla Foods
December 12, 2012
December 24, 2012
January 26, 2017
December 2012
August 2017   (Final data collection date for primary outcome measure)
Infections episodes (gastrointestinal and upper and lower respiratory infections) [ Time Frame: 4 yrs ]
Same as current
Complete list of historical versions of study NCT01755481 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Focus on Healthy Infants
  • Other: Probiotic
  • Other: Whey protein concentrate
  • Experimental: Probiotics F19
    F19 in an infant formula
    Intervention: Other: Probiotic
  • Experimental: Whey protein concentrate
    Whey protein concentrate in an infant formula
    Intervention: Other: Whey protein concentrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
August 2017
August 2017   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
up to 2 Weeks   (Child)
Yes
Contact: Yongmei Peng, M.D., Ph.D., ympeng99@yahoo.com
Contact: Xiaonan Li, M.D., Ph.D., xiaonan6189@yahoo.com
China
 
 
NCT01755481
327727-2
No
Not Provided
Not Provided
Arla Foods
Arla Foods
Not Provided
Principal Investigator: Yongmei Peng, M.D., Ph.D. Children's Hospital, Fudan University, Shanghai, China
Arla Foods
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP