NCT05695300

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Bellamy's Organic Pty Ltd · Industry
• Sex: All
• Age: 30 Days – 30 Days
• Healthy volunteers: Accepted

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.

Conditions

• Infant Development

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BLM 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_SUPPLEMENT	BLM ORGANIC	Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
DIETARY_SUPPLEMENT	Breast milk	Participants in this arm need to be fed with breast milk daily for three months, no infant formula

Timeline

• Start date: 2023-02-03
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2023-01-25
• Last updated: 2023-04-13

Locations

1 site across 1 country: China