Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-23 @ 8:46 AM
Study NCT ID:
NCT04112056
Status:
UNKNOWN
Last Update Posted:
2020-04-02
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose: A Before-after Trial
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: