| Registry | NCT07886424 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 71 (Actual) |
| Sponsor | Tsinghua University (Other); collaborators: Mengniu Institute of Nutrition Science, Global R&D Innovation Center, Beijing |
| Conditions | Infant Growth and Development, Gut Microbiota |
| Interventions | Organic infant formula and organic complementary foods, Conventional infant formula and conventional complementary foods (Other) |
| Dates | start 2022-04-22, primary completion 2023-09-24, completion 2023-09-24, first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 3 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Infant Growth and Development All trials for Gut Microbiota All trials of Organic infant formula and organic complementary foods All trials of Conventional infant formula and conventional complementary foods
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.
Infants in the organic-feeding group received Bellamy's organic infant formula, with organic complementary foods introduced at approximately 5 to 6 months. Infants in the conventional-feeding group received conventional infant formula and conventional complementary foods. Breastfed infants formed a natural reference group; the choice and order of complementary foods were not assigned by the investigators. Follow-up included body weight, recumbent length, head circumference, Ages and Stages Questionnaires, gastrointestinal comfort and stool questionnaires, and fecal sampling for 16S rRNA microbiota analysis. Breast milk samples were collected in the breastfeeding group. The final report describes 32 breastfed, 27 organic-formula-fed, and 12 conventional-formula-fed infants recruited, with 30, 24, and 12, respectively, completing follow-up. Analyses included longitudinal models and per-protocol or sensitivity analyses. This description distinguishes recruitment counts from the numbers completing follow-up and does not report the planned sample size as actual enrollment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Organic Feeding Group | Experimental | Other: Organic infant formula and organic complementary foods | Infants received Bellamy's Stage 1 organic formula from enrollment until 6 months of age, followed by Stage 2 organic formula. Organic complementary foods were introduced at approximately 5 to 6 months, starting with iron-rich purees and progressing to a diversified diet. By 9 months, at least eight complementary foods were recommended: two cereals, five vegetables or fruits, and one meat. Follow-up continued to 8 months of age. |
| Conventional Feeding Group | Active comparator | Other: Conventional infant formula and conventional complementary foods | Infants received conventional Stage 1 infant formula from enrollment to 6 months, followed by conventional Stage 2 formula to 8 months. Conventional complementary foods were introduced at approximately 5 to 6 months, beginning with iron-rich purees and progressing to a diversified diet. Before 9 months, at least eight complementary foods were recommended, including two cereals, five vegetables or fruits, and one meat. |
| Breastfeeding Reference Group | No intervention | Infants were breastfed, with exclusive breastfeeding planned until 6 months of age. Complementary foods were introduced at approximately 5 to 6 months. Investigators did not assign the order or categories of complementary foods, and family feeding practices were documented. This group served as a natural reference, with follow-up through 8 months of age. |
Sex: All, ages: 0 Months to 2 Months, accepts healthy volunteers
Inclusion Criteria: * Term infants born at 37 to 41 weeks of gestation. * Birth weight of 2.5 to 4 kg. * Infants from uncomplicated pregnancy and delivery, including cesarean delivery. * Physically healthy infants with an Apgar score greater than 7 at 5 to 10 minutes after birth. * For the formula-feeding intervention groups, exclusive or predominant formula feeding, with formula accounting for more than 70% of feeding occasions. * For the breastfeeding reference group, mothers planned exclusive breastfeeding for the first 6 months. * Parental or guardian informed consent. Exclusion Criteria: * Twins or other multiple births. * Congenital disabilities. * Known metabolic disorders or other major illnesses, including cardiac, respiratory, gastrointestinal, or other systemic disorders. * Antibiotics or other gut microbiota regulators at enrollment. * Lactose intolerance or cow's milk protein allergy.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |