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Recruiting NCT07534735

Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial

No phase Interventional Infant Growth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigational Formula 1, Investigational Formula 2.
Who it may be relevant to
Registry conditions: Infant Growth. Basic parameters: 12 months — 18 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With Novel Infant Formula : A Randomized Trial

Overview

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 supplement Investigational Formula 1
    The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
  • Dietary supplement Investigational Formula 2
    The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

Primary outcome measures

  • Change in Height [Time frame: Baseline (Day -7) to Day 90]
  • Change in Weight [Time frame: Baseline (Day -7) to Day 90]
  • Comprehensive Nutritional Development Assessment [Time frame: Baseline (Day -7) to Day 90]
Secondary outcome measures (10)
  • Change in Salivary sIgA [Time frame: Baseline (Day -7) to Day 90]
  • Change in Salivary Lysozyme [Time frame: Baseline (Day -7) to Day 90]
  • Change in Fecal sIgA [Time frame: Baseline (Day -7) to Day 90]
  • Change in Fecal Calprotectin [Time frame: Baseline (Day -7) to Day 90]
  • Change in Fecal Alpha-1 Antitrypsin (AAT) [Time frame: Baseline (Day -7) to Day 90]
  • Change in Gut Microbiome Composition (Metagenomics) [Time frame: Baseline (Day -7) to Day 90]
  • Change in Fecal Metabolome (Non-targeted Metabolomics) [Time frame: Baseline (Day -7) to Day 90]
  • Change in IGSQ Score [Time frame: Baseline (Day -7) to Day 90]
  • Change in Stool Consistency (Brussels Infant Stool Hardness Scale) [Time frame: Baseline (Day -7) to Day 90]
  • Change in TSAS Score [Time frame: Baseline (Day -7) to Day 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Shenzhen University — Shenzhen

Identifiers

NCT: NCT07534735 · PFNF-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗