Growth and health effects of a novel infant formula in 12- to 18-month-olds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial compares three parallel arms to evaluate the impact of investigational formulas on growth trajectories, gut health markers, immune function, and sleep status in healthy infants and young children aged 12–18 months. Eligible participants are healthy, full-term infants who have begun stage 3 formula feeding and are below the 75th percentile for weight. The study excludes those with milk protein allergies, high allergy risk, malnutrition, chronic diseases, or recent NICU admission. The trial is sponsored by Biostime (Changsha) Nutrition Foods Limited with collaboration from Shenzhen University, located in Shenzhen, Guangdong. Primary outcomes include growth measurements and selected physiological markers; safety and tolerability will also be monitored.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shenzhen University
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Pantian Huang
• Email: umi.huang@hh.global
• Phone: +86 13430375474

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.