The Impact of Infant Formula With Probiotics on Infants Health
1 other identifier
interventional
159
1 country
1
Brief Summary
The trial will be divided into three groups, the experimental group: (I) probiotic A formula, (II) probiotic B formula; control group: (III) regular formula (Youluck infant formula). Inclusion criteria included: (1) the normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams and (2) subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents. Exclusion criteria included: infants with chronic diarrhea, hemangioma, cerebral hemorrhage, severe asphyxia (stage III), fetal chromosomal abnormalities, cyanotic congenital heart disease, intestinal hypoplasia or abnormal immune function after birth, liver failure, breastfeeding within two months after birth, taking other probiotic products within two weeks after birth, treatment with antibiotics during acute infection and diagnosis of allergies, gastroenteritis, respiratory infections will be excluded. The study will be conducted for half a year, 5 cans of Youluck infant formula are provided for each subject during the test period. The Youluck infant formula is sponsored free of charge by glac biotech Co., Ltd. During hospitalization, the infant will be feed by same group of experienced nurses and all infants will be monitored for adverse conditions such as vomiting, diarrhea or bloating every day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Typical duration 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
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 19, 2023
March 1, 2023
4 months
June 19, 2019
July 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of treatment-emergent adverse events
All babies are monitored for adverse events such as vomiting, diarrhea or bloating.
6 month follow-up.
Change in body weight
The baby will record the body weight before taking infant formula. During the half-year trial period, the body weight will also be measured every 2 months.
6 month follow-up.
Change in body height
The baby will record the body height before taking infant formula. During the half-year trial period, the body height will also be measured every 2 months.
6 month follow-up.
Change in head circumference
The baby will record the head circumference before taking infant formula. During the half-year trial period, the head circumference will also be measured every 2 months.
6 month follow-up.
Secondary Outcomes (3)
The occurrence of inflammatory bowel diseases
6 month follow-up.
The occurrence of allergic diseases
6 month follow-up.
The occurrence of respiratory infection
6 month follow-up.
Study Arms (3)
Probiotic A formula
EXPERIMENTALInfant Formula with Lactobacillus salivarius AP-32
Probiotic B formula
EXPERIMENTALInfant Formula with Bifidobacterium animalis subsp. lactis CP-9
Regular formula
PLACEBO COMPARATORThe infant formula without any probiotic.
Interventions
Feeding baby two meals a day with Infant formula with probiotics (10\^8 colony-forming unit per day) at least.
Feeding baby two meals a day with Infant formula with probiotics (10\^8 colony-forming unit per day) at least.
Eligibility Criteria
You may qualify if:
- The normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams.
- Subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents.
You may not qualify if:
- Chronic diarrhea
- Hemangioma
- Cerebral hemorrhage
- Severe asphyxia (stage III)
- Fetal chromosomal abnormalities
- Cyanotic congenital heart disease
- Intestinal hypoplasia or abnormal immune function after birth.
- Liver failure
- Breastfeeding within two months after birth.
- Taking other probiotic products within two weeks after birth.
- Treatment with antibiotics during acute infection and diagnosis of allergies.
- Gastroenteritis
- Respiratory infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Medical University Hospitallead
- Glac Biotech Co., Ltdcollaborator
Study Sites (1)
Department of Pediatrics, Children Hospital, China Medical University
Taichung, 404, Taiwan
Related Publications (1)
Shen SP, Lin HC, Chen JF, Wang HS, Huang YY, Hsia KC, Lin JH, Kuo YW, Li CM, Hsu YC, Tsai SY, Ho HH. Assessment of the safety and gut microbiota modulation ability of an infant formula containing Bifidobacterium animalis ssp. lactis CP-9 or Lactobacillus salivarius AP-32 and the effects of the formula on infant growth outcomes: insights from a four-month clinical study in infants under two months old. BMC Pediatr. 2024 Dec 27;24(1):840. doi: 10.1186/s12887-024-05289-7.
PMID: 39731060DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Chih Lin
China Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
June 19, 2019
First Posted
June 20, 2019
Study Start
February 11, 2020
Primary Completion
June 16, 2020
Study Completion
December 31, 2022
Last Updated
July 19, 2023
Record last verified: 2023-03