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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
  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
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

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 ]

Estimated Enrollment: 800
Study Start Date: December 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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


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

Responsible Party: Arla Foods
ClinicalTrials.gov Identifier: NCT01755481     History of Changes
Other Study ID Numbers: 327727-2
First Submitted: December 12, 2012
First Posted: December 24, 2012
Last Update Posted: January 26, 2017
Last Verified: January 2017


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