Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
ConditionInfant Growth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBiostime (Changsha) Nutrition Foods Limited
About this trial
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
Eligibility criteria
Qualifiers
Healthy full-term infants (gestational age 37-42 weeks).
Age 12-18 months (inclusive).
Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".
Has started or plans to start stage 3 formula feeding before enrollment.
Disqualifiers
Known allergy to milk protein or the study formula.
Known allergic constitution or high allergy risk (parent with allergic constitution).
Malnutrition assessed by investigator.
Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.
Trial design
Treatments tested in this trial
- Investigational Formula 1
- Investigational Formula 2
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Biostime (Changsha) Nutrition Foods Limited
Lead sponsor
Shenzhen University
Collaborator
Source ClinicalTrials.gov