Status:
UNKNOWN
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
Lead Sponsor:
Peking University
Collaborating Sponsors:
Huantai Maternal and Child Health Care Hospital
Conditions:
Infant Nutrition Disorders
Gastrointestinal Dysfunction
Eligibility:
All Genders
7-6 years
Phase:
NA
Brief Summary
The study is a before-after trial to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infan...
Detailed Description
Mild gastrointestinal disorders in infants belong to the category of functional gastrointestinal disorders. It refers that the infants fed with formula have mild digestive dysfunction that can not be ...
Eligibility Criteria
Inclusion
- Obtaining the informed consent of infants' parents or guardians
- Term infants (≥37 gestational weeks)
- Healthy infants aged 7-180 days
- Formula feeding or mixed feeding
- With mild gastrointestinal disorders
- Drinking the study formula more than half of the total diet daily
Exclusion
- Adding new auxiliary food in the latest week
- Any kind of probiotics is being used
- Using drugs
- Using the formula being studied
- Having a history of milk protein allergies according to parents' reports
- Can not follow the research plans
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04112056
Start Date
October 10 2019
End Date
May 15 2020
Last Update
April 2 2020
Active Locations (1)
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1
Huantai Maternal and Child Health Care Hospital
Zibo, Shandong, China, 256499