- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405572
Feeding Tolerance Evaluation
May 11, 2016 updated by: Nestlé
Crossover study of 2 infant formulas
Study Overview
Detailed Description
Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas.
Daily tolerance records will be kept by caregivers.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Owensboro, Kentucky, United States, 47630
- Pedia Research
-
-
Utah
-
Layton, Utah, United States, 84041
- Tanner Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy newborn infant
- Full-term (> 37 weeks gestation)
- 0-2 months (birth-56 days) of age on enrollment
- Infant exclusively formula-fed for at least 2 days prior to enrollment
- Having obtained his/her legal representative's informed consent
Exclusion Criteria:
- Known or suspected cow-milk allergy
- Congenital illness or malformation
- Significant prenatal and/or postnatal disease
- Currently participating in another clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Formula 1
infant formula
|
infant formulas
|
ACTIVE_COMPARATOR: Formula 2
infant formula
|
infant formulas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stool consistency
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spit-up pattern
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
formula intake
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
adverse events
Time Frame: 2 weeks
|
assessed throughout the study
|
2 weeks
|
stool pattern
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
mood
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
sleep pattern
Time Frame: 2 weeks
|
caregivers will document on diary records
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rich Litov, PhD, Pedia Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
February 23, 2015
First Submitted That Met QC Criteria
March 27, 2015
First Posted (ESTIMATE)
April 1, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14.32.US.INF
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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