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Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

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ClinicalTrials.gov Identifier: NCT01755481
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Arla Foods

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

Condition or disease Intervention/treatment Phase
Focus on Healthy Infants Other: Probiotic Other: Whey protein concentrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
Study Start Date : December 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Infections episodes (gastrointestinal and upper and lower respiratory infections) [ Time Frame: 4 yrs ]


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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755481


Locations
China
Department of Child Health Care, Children's Hospital, Fudan University
Shanghai, China
Sponsors and Collaborators
Arla Foods
Investigators
Principal Investigator: Yongmei Peng, M.D., Ph.D. Children's Hospital, Fudan University, Shanghai, China

Responsible Party: Arla Foods
ClinicalTrials.gov Identifier: NCT01755481     History of Changes
Other Study ID Numbers: 327727-2
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018