Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
NCT ID: NCT04112056
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-10-10
2020-05-15
Brief Summary
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Detailed Description
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The purpose of the study is to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. After informed consent, 90 infants between 7 days and 6 months old with mild gastrointestinal disorders are included and asked to drink the study formula for 14 consecutive days as intervention. On Day 0 (the time of enrolling group, but the intervention begins on Day 1), Day 7, Day 14, the information on gastrointestinal comfort and related behaviors is collected through the Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13). Information on feeding, family background, anthropometric measurements and defecation is also collected. The primary endpoint of this study is gastrointestinal comfort calculated by IGSQ-13. The secondary endpoints include crying frequency, spitting milk frequency, flatulence frequency, stool frequency and consistency score, formula acceptability and satisfaction, adverse event, etc.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study formula
The infants recruited are provided with the study formula named NAN Comfort producted by Nestle Deutschland AG, Werk Biessenhofen containing moderately hydrolyzed protein and low lactose for free during study, and asked to drink the study formula more than half of the total diet daily.
Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
It is same as that stated in arm description.
Interventions
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Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
It is same as that stated in arm description.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
7 Days
6 Months
ALL
Yes
Sponsors
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Huantai Maternal and Child Health Care Hospital
UNKNOWN
Peking University
OTHER
Responsible Party
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Jianmeng Liu
Professor in Perinatal Epidemiology
Principal Investigators
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Jian-meng Liu, PhD
Role: STUDY_CHAIR
Peking University
Ying-chao Mu, BD
Role: STUDY_DIRECTOR
Huantai Maternal and Child Health Care Hospital
Locations
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Huantai Maternal and Child Health Care Hospital
Zibo, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Huang Y, Zhou Y, Li H, Chen Y, Mu Y, Yuan A, Yang Y, Liu J. The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. Nutrients. 2021 Sep 25;13(10):3371. doi: 10.3390/nu13103371.
Other Identifiers
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PKUFM.191010
Identifier Type: -
Identifier Source: org_study_id
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