To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants
A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants
1 other identifier
interventional
284
1 country
6
Brief Summary
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits. Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age. Safety, growth and tolerance parameters will be followed and collected throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Typical duration for not_applicable
6 active sites
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
March 11, 2018
CompletedStudy Start
First participant enrolled
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2020
CompletedFebruary 26, 2021
February 1, 2021
1.9 years
March 11, 2018
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Weight gain per day from baseline (g/day)
at the age of 17 weeks
Secondary Outcomes (13)
Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.
at the age of 17 weeks
Increment per day from baseline on length (mm/day)
at the age of 17 weeks
Increment per day from baseline on head circumference (mm/day)
at the age of 17 weeks
Increment per day from baseline on mid-upper arm circumference (mm/day)
at the age of 17 weeks
Z-scores of anthropometric parameters from baseline on weight
from baseline until the age of 17 weeks
- +8 more secondary outcomes
Study Arms (3)
New infant formula with synbiotics
EXPERIMENTALpHP infant formula with synbiotics (test product)
Standard infant formula with prebiotics
ACTIVE COMPARATORStandard (commercial) infant formula with prebiotics (control product)
human milk
NO INTERVENTIONFull breastfeeding for at least 17 weeks
Interventions
Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.
Eligibility Criteria
You may qualify if:
- Healthy Chinese term infants ≤ 44 days
- Birth weight within normal range
- Head circumference within normal range
- Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age
You may not qualify if:
- \- The mothers of infants:
- who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
- \- Parents/Legally acceptable representatives/Caregivers of infants:
- who are incapable to comply with study protocol
- \- Infants:
- who have to be fed with a special diet other than standard cow's milk based infant formula;
- known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
- known or suspected to have an allergic condition towards cow's milk, soy or fish;
- with any history of, or current participation in any other study involving investigational or marketed products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danone Nutricialead
- Nutricia Early Life Nutrition (Shanghai) Co., Ltdcollaborator
Study Sites (6)
Peking University 3rd Hospital
Beijing, Beijing Municipality, China
Guangzhou women and Children's Medical Center
Guangzhou, Guangdong, 510623, China
Guangdong Province Maternal and Children Hospital
Guangzhou, Guangdong, China
Wuxi Poeple's Hospital
Wuxi, Jiangsu, China
Shanghai Public Health Clinical Research Center
Shanghai, Shanghai Municipality, China
Xin Hua Hospital
Shanghai, Shanghai Municipality, China
Related Publications (1)
Wang Y, Wopereis H, Kakourou A, Liu M, Wu J, Li Z, Zhang L, Tan M, Low JSY, Liu M, Roeselers G, Knol J, Cai W. Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section. Eur J Clin Nutr. 2025 Jun;79(6):567-575. doi: 10.1038/s41430-025-01571-8. Epub 2025 Feb 6.
PMID: 39915586DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2018
First Posted
May 11, 2018
Study Start
April 3, 2018
Primary Completion
March 6, 2020
Study Completion
November 9, 2020
Last Updated
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share