Clinical trial NCT04112056: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Nutrition Disorders
Gastrointestinal Dysfunction
Keywords: Mild gastrointestinal disorders
Infant formula
Infant gastrointestinal symptoms questionnaire
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Huantai Maternal and Child Health Care Hospital
First posted: 2019-10-02
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
timeFrame: On Day 0 (the time of enrolling group)
measure: Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
timeFrame: On Day 7
measure: Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
timeFrame: On Day 14
Secondary outcomes:
measure: Crying frequency
timeFrame: On Day 0, Day 7 and Day 14
measure: Spitting milk frequency
timeFrame: On Day 0, Day 7 and Day 14
measure: Flatulence frequency
timeFrame: On Day 0, Day 7 and Day 14
measure: Stool frequency and consistency
timeFrame: On Day 1, Day 2 and Day 3
measure: Formula acceptability and satisfaction
timeFrame: On Day 14
measure: Adverse event frequency
timeFrame: Day1 to Day 14
Other outcomes:
Locations:
city: Zibo
country: China
facility: Huantai Maternal and Child Health Care Hospital
state: Shandong
Study officials:
affiliation: Peking University
name: Jian-meng Liu, PhD
role: STUDY_CHAIR
affiliation: Huantai Maternal and Child Health Care Hospital
name: Ying-chao Mu, BD
role: STUDY_DIRECTOR
References:
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.