Infant Growth
Conditions
Keywords
Human Milk Oligosaccharides, Infant Formula, Infant Growth, Gut Health, Immune Function, Sleep, Randomized Controlled Trial
Brief summary
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
Interventions
DIETARY_SUPPLEMENTInvestigational Formula 1
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
DIETARY_SUPPLEMENTInvestigational Formula 2
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
Sponsors
Biostime (Changsha) Nutrition Foods Limited
Shenzhen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy full-term infants (gestational age 37-42 weeks). * Age 12-18 months (inclusive). * Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old". * Has started or plans to start stage 3 formula feeding before enrollment. * Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests.
Exclusion criteria
* Known allergy to milk protein or the study formula. * Known allergic constitution or high allergy risk (parent with allergic constitution). * Malnutrition assessed by investigator. * Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development. * History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice. * Severe constipation or diagnosis of other functional gastrointestinal disorders. * Cognitive or developmental disorders. * Any other condition that, in the investigator's judgment, makes the infant unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Height | Baseline (Day -7) to Day 90 | Measured in centimeters (cm) |
| Change in Weight | Baseline (Day -7) to Day 90 | Measured in kilograms (kg) |
| Comprehensive Nutritional Development Assessment | Baseline (Day -7) to Day 90 | (1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary sIgA | Baseline (Day -7) to Day 90 | Saliva sample collected in microliters (µL) |
| Change in Salivary Lysozyme | Baseline (Day -7) to Day 90 | Saliva sample collected in microliters (µL) |
| Change in Fecal sIgA | Baseline (Day -7) to Day 90 | Stool sample collected |
| Change in Fecal Calprotectin | Baseline (Day -7) to Day 90 | Stool sample collected |
| Change in Fecal Alpha-1 Antitrypsin (AAT) | Baseline (Day -7) to Day 90 | Stool sample collected |
| Change in Gut Microbiome Composition (Metagenomics) | Baseline (Day -7) to Day 90 | Stool sample collected for metagenomic sequencing |
| Change in Fecal Metabolome (Non-targeted Metabolomics) | Baseline (Day -7) to Day 90 | Stool sample collected for metabolomic analysis |
| Change in IGSQ Score | Baseline (Day -7) to Day 90 | Questionnaire administered by site staff |
| Change in Stool Consistency (Brussels Infant Stool Hardness Scale) | Baseline (Day -7) to Day 90 | Questionnaire administered by site staff |
| Change in TSAS Score | Baseline (Day -7) to Day 90 | Questionnaire administered by site staff |
Countries
China
Contacts
CONTACTPantian Huang
CONTACTSiwan Peng
Outcome results
None listed