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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02746016
Other study ID # AL19
Secondary ID
Status Completed
Phase N/A
First received April 13, 2016
Last updated March 28, 2017
Start date April 2016
Est. completion date October 2016

Study information

Verified date March 2017
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Infant Formula supplemented with Oligosaccharides
sole source nutrition

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Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fussiness Parent Questionnaires Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Secondary Fussiness Parent Questionnaires Baseline to SDAY 29
Secondary Hours of daily crying Parent Questionnaires Baseline to SDAY 29
Secondary Gastrointestinal Tolerance Parent Questionnaires Baseline to SDAY 29
Secondary Stool Pattern Parent Questionnaire Baseline to SDAY 29
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