- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755481
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shanghai, China
- Department of Child Health Care, Children's Hospital, Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotics F19
F19 in an infant formula
|
|
Experimental: Whey protein concentrate
Whey protein concentrate in an infant formula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infections episodes (gastrointestinal and upper and lower respiratory infections)
Time Frame: 4 yrs
|
4 yrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yongmei Peng, M.D., Ph.D., Children's Hospital, Fudan University, Shanghai, China
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 327727-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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