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COMPLETED
NCT07886424
NA

The Impact of Early-life Organic Feeding on Infants' Health: A Cluster Randomized Controlled Trial

Sponsor: Tsinghua University

View on ClinicalTrials.gov

Summary

This completed study compared early-life feeding with organic infant formula and organic complementary foods, conventional infant formula and conventional complementary foods, and breastfeeding with family-selected complementary foods. Infants were recruited in Chenzhou, Hunan, China, and followed through 8 months of age. The study examined physical growth, early development, gastrointestinal symptoms, stool characteristics, and gut microbiota. Measurements and questionnaires were collected at baseline and scheduled visits at 2, 4, 6, and 8 months of age. The aim was to assess whether organic feeding was associated with differences in infant health and gut microbiota compared with conventional feeding, with breastfeeding as a natural reference. Registration is being completed retrospectively after the study has finished.

Key Details

Gender

All

Age Range

0 Months - 2 Months

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2022-04-22

Completion Date

2023-09-24

Last Updated

2026-10-21

Healthy Volunteers

Yes

Interventions

OTHER

Organic infant formula and organic complementary foods

Age-appropriate organic infant formula and organic complementary foods were provided according to the feeding schedule described for the Organic Feeding Group.

OTHER

Conventional infant formula and conventional complementary foods

Age-appropriate conventional infant formula and conventional complementary foods were provided according to the feeding schedule described for the Conventional Feeding Group.

Locations (3)

Chenzhou Maternal and Child Health Hospital (Main Campus)

Chenzhou, Hunan, China

Chenzhou Maternal and Child Health Hospital (Suxian Campus)

Chenzhou, Hunan, China

Guiyang Maternal and Child Health Hospital

Chenzhou, Hunan, China