A Randomized, Double-blind, Controlled Study to Evaluate the Gut Health, Feces Characteristics and Growth of Healthy Term Infants Fed With a New Infant Organic Formula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bellamy's Organic Pty Ltd
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in stool consistency, color and amount
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Days to 30 Days (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
BLM ORGANIC GOLD+
BLM ORGANIC GOLD+ infant formula,800g/can
Intervention: BLM ORGANIC GOLD+ (Dietary Supplement)
BLM ORGANIC
BLM ORGANIC infant formula,800g/can
Intervention: BLM ORGANIC (Dietary Supplement)
Breast milk
Mother's breast milk
Intervention: Breast milk (Dietary Supplement)
Outcomes
Primary Outcomes
Change in stool consistency, color and amount
Time Frame: over 3 months
Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months
Secondary Outcomes
- Frequency of adverse events(baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90)
- Change rate of baby weight(baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90)
- Average daily intake of formula(baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90)
- Change rate of baby length(baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90)
- Change rate of baby head circumference(baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90)