Infant Development
Conditions
Keywords
infant formula, gut health, feces
Brief summary
The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula). 75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months. Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.
Detailed description
This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.
Interventions
DIETARY_SUPPLEMENTBLM ORGANIC GOLD+
Participants in this arm need to be fed the assigned infant formula daily for three months, no other formula or breast milk
DIETARY_SUPPLEMENTBLM ORGANIC
Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
DIETARY_SUPPLEMENTBreast milk
Participants in this arm need to be fed with breast milk daily for three months, no infant formula
Sponsors
Bellamy's Organic Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Days to 30 Days
Healthy volunteers
Yes
Inclusion criteria
* 30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0) * Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group) * Singleton birth * Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days) * Birth weight of 2490g to 4200g * Signed informed consent obtained for infant's and mother's participation in the study
Exclusion criteria
* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant * Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion) * Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein * Weight at randomization is \<90% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<90%\] * Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) * Known head/brain disease/injury such as microcephaly, macrocephaly or others. * Enrollment in another interventional clinical research study while participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool consistency, color and amount | over 3 months | Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change rate of baby length | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | Change rate in mm/day of baby length for each visit interval |
| Change rate of baby head circumference | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | Change rate in mm/day of baby head circumference for each visit interval |
| Change rate of baby weight | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | Change rate in gram/day of baby weight for each visit interval |
| Average daily intake of formula | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | Average daily intake of formula in gram or ml for each visit interval |
| Frequency of adverse events | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 | Frequency of adverse events for each visit interval |
Countries
China
Outcome results
None listed