Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula

Bellamy's Organic

Status: Active, not recruiting

Conditions: Infant Development

Treatments: Dietary Supplement: Breast milk; Dietary Supplement: BLM ORGANIC; Dietary Supplement: BLM ORGANIC GOLD+

Study type: Interventional

Funder types: Industry

Identifiers

NCT05695300

22-SM-10-BLM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 30 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

BLM ORGANIC GOLD+

Active Comparator group

Description:

BLM ORGANIC GOLD+ infant formula,800g/can

Treatment:

Dietary Supplement: BLM ORGANIC GOLD+

BLM ORGANIC

Placebo Comparator group

Description:

BLM ORGANIC infant formula,800g/can

Treatment:

Dietary Supplement: BLM ORGANIC

Breast milk

Other group

Description:

Mother's breast milk

Treatment:

Dietary Supplement: Breast milk