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

NCT05695300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

  • Infant Development

Interventions

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

Sponsors & Collaborators

  • Bellamy's Organic Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaoyang Sheng, MD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695300 on ClinicalTrials.gov