Status:
COMPLETED
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
Lead Sponsor:
Meiji Co., Ltd.
Conditions:
Low Birth Weight Infants
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human...
Eligibility Criteria
Inclusion
- 1-1) For infants
- i. Low birth weight infants (defined as a birth weight ≥1,500 g and \<2,500 g) during hospitalization and may require milk powder formula as supplement.
- 1-2) For mothers
- i. Mothers who do not find serious viral infection
- ii. Mothers who are willing to provide consent for provision of study required information and specimen(s) from both mothers and infants
- iii. Mothers who are willing to provide consent as infant's legally acceptable representative (LAR)
Exclusion
- 2-1) For infants
- i. Infants who receive any formulas before Informed Consent.
- ii. Infants with serious infections.
- iii. Infants with necrotizing enteritis.
- iv. Infants with gastrointestinal perforation.
- v. Infants whom the PI determines inappropriate as a study subject (e.g. inflammatory, metabolic abnormalities and difficulty in enteral feeding).
- 2-2) For mothers
- i. Mothers the PI determines inappropriate as a study subject
- ii. Mothers under 18 years old.
- Withdrawal criteria:
- A subject must be discontinued from treatment with test formula if any of the following apply:
- i. If the mother, who is a subject of the study as well as infant's LAR , asks for withdrawal from the study or withdraws consent.
- ii. When a serious adverse event occurs.
- iii. When an adverse event occurs, and the PI or co-investigator determines that the study should be discontinued.
- iv. If it is decided that there is a risk of compromising the safety of the study subject.
- v. If a subject is found to be ineligible after the start of the study.
- vi. If it is found that there is a serious or continued non-compliance with the study protocol by a study subject.
- vii. In addition, if the PI decides to end the study.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05203900
Start Date
December 13 2021
End Date
May 24 2023
Last Update
July 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330