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

Infant Development Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05695300
Study type Interventional
Source Bellamy's Organic Pty Ltd
Contact
Status Active, not recruiting
Phase N/A
Start date February 3, 2023
Completion date May 31, 2023
View Details
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