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

Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant Growth
• Intervention / Treatment: Dietary supplement: Investigational Formula 1; Dietary supplement: Investigational Formula 2

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pantian Huang; Phone Number: +86 13430375474; Email: umi.huang@hh.global
• Study Contact Backup: Name: Siwan Peng; Phone Number: +86 13543117452; Email: pengsiwan@zhunter.com.cn

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518060
      • Shenzhen University
      • Contact: Pantian Huang; Phone Number: +86 13430375474; Email: umi.huang@hh.global
      • Contact: Siwan Peng; Phone Number: +86 13543117452; Email: pengsiwan@zhunter.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Formula 1	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
Experimental: Investigational Formula 2	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
No Intervention: Control: Commercial Infant Formula or Dairy Products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Height	Measured in centimeters (cm)	Baseline (Day -7) to Day 90
Change in Weight	Measured in kilograms (kg)	Baseline (Day -7) to Day 90
Comprehensive Nutritional Development Assessment	(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).	Baseline (Day -7) to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary sIgA	Saliva sample collected in microliters (µL)	Baseline (Day -7) to Day 90
Change in Salivary Lysozyme	Saliva sample collected in microliters (µL)	Baseline (Day -7) to Day 90
Change in Fecal sIgA	Stool sample collected	Baseline (Day -7) to Day 90
Change in Fecal Calprotectin	Stool sample collected	Baseline (Day -7) to Day 90
Change in Fecal Alpha-1 Antitrypsin (AAT)	Stool sample collected	Baseline (Day -7) to Day 90
Change in Gut Microbiome Composition (Metagenomics)	Stool sample collected for metagenomic sequencing	Baseline (Day -7) to Day 90
Change in Fecal Metabolome (Non-targeted Metabolomics)	Stool sample collected for metabolomic analysis	Baseline (Day -7) to Day 90
Change in IGSQ Score	Questionnaire administered by site staff	Baseline (Day -7) to Day 90
Change in Stool Consistency (Brussels Infant Stool Hardness Scale)	Questionnaire administered by site staff	Baseline (Day -7) to Day 90
Change in TSAS Score	Questionnaire administered by site staff	Baseline (Day -7) to Day 90

Collaborators and Investigators

• Sponsor: Biostime (Changsha) Nutrition Foods Limited
• Collaborators: Shenzhen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Randomized Controlled Trial; Immune Function; Infant Formula; Gut Health; Human Milk Oligosaccharides; Infant Growth
• Other Study ID Numbers: PFNF-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No