NCT07534735

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Infant Growth

Keywords

Human Milk OligosaccharidesInfant FormulaInfant GrowthGut HealthImmune FunctionSleepRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Change in Salivary sIgA

    Baseline (Day -7) to Day 90

  • Change in Salivary Lysozyme

    Baseline (Day -7) to Day 90

  • Change in Fecal sIgA

    Baseline (Day -7) to Day 90

  • Change in Fecal Calprotectin

    Baseline (Day -7) to Day 90

  • Change in Fecal Alpha-1 Antitrypsin (AAT)

    Baseline (Day -7) to Day 90

  • +5 more secondary outcomes

Study Arms (3)

Investigational Formula 1

EXPERIMENTAL
Dietary Supplement: Investigational Formula 1

Investigational Formula 2

EXPERIMENTAL
Dietary Supplement: Investigational Formula 2

Control: Commercial Infant Formula or Dairy Products

NO INTERVENTION

Interventions

Investigational Formula 1DIETARY_SUPPLEMENT

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

Investigational Formula 1
Investigational Formula 2DIETARY_SUPPLEMENT

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

Investigational Formula 2

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen University

Shenzhen, Guangdong, 518060, China

Location

Central Study Contacts

Pantian Huang

CONTACT

+86 13430375474umi.huang@hh.global

Siwan Peng

CONTACT

+86 13543117452pengsiwan@zhunter.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

CN(1)