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

Recruiting now · Not applicable

Conditions studied: Infant Growth

In brief

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.

Key facts

Study ID

NCT07534735

Run by

Biostime (Changsha) Nutrition Foods Limited

People needed

120

Starts

2026-05-27

Expected to finish

2027-01-01

Last updated by the study team

2026-06-16

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Shenzhen University — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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