Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
1 other identifier
interventional
90
1 country
1
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 infants. The study plans to recruit 90 infants between 7 days and 6 months old in Huantai Maternal and Child Health Care Hospital in Shandong Province and intervene for 14 consecutive days. On Day 0 (the time of enrolling group, but the intervention which infants recruited are asked to drink study formula begins on Day 1), Day 7, Day 14, Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) is used to collect infants gastrointestinal comfort, related behaviors and other information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedStudy Start
First participant enrolled
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedApril 2, 2020
March 1, 2020
7 months
September 26, 2019
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
On Day 0 (the time of enrolling group)
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
On Day 7
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
On Day 14
Secondary Outcomes (6)
Crying frequency
On Day 0, Day 7 and Day 14
Spitting milk frequency
On Day 0, Day 7 and Day 14
Flatulence frequency
On Day 0, Day 7 and Day 14
Stool frequency and consistency
On Day 1, Day 2 and Day 3
Formula acceptability and satisfaction
On Day 14
- +1 more secondary outcomes
Study Arms (1)
Study formula
EXPERIMENTALThe 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.
Interventions
It is same as that stated in arm description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Universitylead
- Huantai Maternal and Child Health Care Hospitalcollaborator
Study Sites (1)
Huantai Maternal and Child Health Care Hospital
Zibo, Shandong, 256499, China
Related Publications (1)
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.
PMID: 34684372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian-meng Liu, PhD
Peking University
- STUDY DIRECTOR
Ying-chao Mu, BD
Huantai Maternal and Child Health Care Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Perinatal Epidemiology
Study Record Dates
First Submitted
September 26, 2019
First Posted
October 2, 2019
Study Start
October 10, 2019
Primary Completion
April 30, 2020
Study Completion
May 15, 2020
Last Updated
April 2, 2020
Record last verified: 2020-03