Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
Primary Purpose
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
Sponsored by
About this trial
This is an interventional prevention trial for Infant Nutrition Disorders focused on measuring Mild gastrointestinal disorders, Infant formula, Infant gastrointestinal symptoms questionnaire
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Huantai Maternal and Child Health Care HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study formula
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Crying frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Spitting milk frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Flatulence frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Stool frequency and consistency
Collecting infants stool photos
Formula acceptability and satisfaction
Collected by a structured questionnaire,which is designed for this study specially, including 5 questions, and will be analyzed separately for each question (no total score used).
Adverse event frequency
Confirmed by doctor
Full Information
NCT ID
NCT04112056
First Posted
September 26, 2019
Last Updated
March 31, 2020
Sponsor
Peking University
Collaborators
Huantai Maternal and Child Health Care Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04112056
Brief Title
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
Official Title
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose: A Before-after Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Huantai Maternal and Child Health Care Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 explained by organic lesions or biochemical abnormalities, mainly including intestinal colic, spitting milk, diarrhea, constipation, etc. Mild gastrointestinal disorders are common in infants aged 0 to 1 year old. A study across 15 cities in China on the prevalence of common gastrointestinal disorders in infants shows that about 1/3 of the infants have one or more types of gastrointestinal disorders, among of which diarrhea and spitting milk are most common, and most of them occur within the age of 6 months. To solve this problem, a special kind of formulas for infants containing moderately hydrolyzed protein and low lactose has been developed, and our study formula is one of them. The study formula has been already marketed in China and passed the test hosted by the comprehensive testing center of the Chinese academy of inspection and quarantine, but whether it can significantly improve the mild gastrointestinal disorders in Chinese infants remains to be evaluated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Keywords
Mild gastrointestinal disorders, Infant formula, Infant gastrointestinal symptoms questionnaire
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study formula
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
Intervention Description
It is same as that stated in arm description.
Primary Outcome Measure Information:
Title
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Description
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.
Time Frame
On Day 0 (the time of enrolling group)
Title
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Description
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.
Time Frame
On Day 7
Title
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Description
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.
Time Frame
On Day 14
Secondary Outcome Measure Information:
Title
Crying frequency
Description
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Time Frame
On Day 0, Day 7 and Day 14
Title
Spitting milk frequency
Description
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Time Frame
On Day 0, Day 7 and Day 14
Title
Flatulence frequency
Description
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Time Frame
On Day 0, Day 7 and Day 14
Title
Stool frequency and consistency
Description
Collecting infants stool photos
Time Frame
On Day 1, Day 2 and Day 3
Title
Formula acceptability and satisfaction
Description
Collected by a structured questionnaire,which is designed for this study specially, including 5 questions, and will be analyzed separately for each question (no total score used).
Time Frame
On Day 14
Title
Adverse event frequency
Description
Confirmed by doctor
Time Frame
Day1 to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-bo Zhou, PhD
Phone
18810533987
Email
zhouyubo@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-hao Cheng, PhD Candidate
Phone
18201307375
Email
2570991826@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-meng Liu, PhD
Organizational Affiliation
Peking University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ying-chao Mu, BD
Organizational Affiliation
Huantai Maternal and Child Health Care Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Huantai Maternal and Child Health Care Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
256499
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying-chao Mu, BD
Phone
13792199881
Email
1319094858@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34684372
Citation
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.
Results Reference
derived
Learn more about this trial
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
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