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NCT Number: NCT07534735

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

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.

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Key information

Conditions

Infant Growth

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Formula 1

Dietary Supplement

The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

Investigational Formula 2

Dietary Supplement

The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

Primary outcomes

  1. Change in Height

    Time frame: Baseline (Day -7) to Day 90

    Measured in centimeters (cm)

  2. Change in Weight

    Time frame: Baseline (Day -7) to Day 90

    Measured in kilograms (kg)

  3. Comprehensive Nutritional Development Assessment

    Time frame: 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 outcomes

  1. Change in Salivary sIgA

    Time frame: Baseline (Day -7) to Day 90

    Saliva sample collected in microliters (µL)

  2. Change in Salivary Lysozyme

    Time frame: Baseline (Day -7) to Day 90

    Saliva sample collected in microliters (µL)

  3. Change in Fecal sIgA

    Time frame: Baseline (Day -7) to Day 90

    Stool sample collected

  4. Change in Fecal Calprotectin

    Time frame: Baseline (Day -7) to Day 90

    Stool sample collected

  5. Change in Fecal Alpha-1 Antitrypsin (AAT)

    Time frame: Baseline (Day -7) to Day 90

    Stool sample collected

  6. Change in Gut Microbiome Composition (Metagenomics)

    Time frame: Baseline (Day -7) to Day 90

    Stool sample collected for metagenomic sequencing

  7. Change in Fecal Metabolome (Non-targeted Metabolomics)

    Time frame: Baseline (Day -7) to Day 90

    Stool sample collected for metabolomic analysis

  8. Change in IGSQ Score

    Time frame: Baseline (Day -7) to Day 90

    Questionnaire administered by site staff

  9. Change in Stool Consistency (Brussels Infant Stool Hardness Scale)

    Time frame: Baseline (Day -7) to Day 90

    Questionnaire administered by site staff

  10. Change in TSAS Score

    Time frame: Baseline (Day -7) to Day 90

    Questionnaire administered by site staff

Study contacts

Contact information is provided by the study sponsor or research team.

Pantian Huang

CONTACT

[email protected]

+86 13430375474

Siwan Peng

CONTACT

[email protected]

+86 13543117452

Sponsors and collaborators

Lead sponsor

Biostime (Changsha) Nutrition Foods Limited

Industry

Collaborators

  • Shenzhen University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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