Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 18, 2024
Date Accepted: Jul 25, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of a ready to feed starter liquid infant formula containing 2’FL and LNnT in Chinese infants: “STARLIT” trial (STARter LIquid infant formula Trial with 2’FL and LNnT in Chinese infants: a double-blind, randomized controlled trial with a breastfed reference group)
ABSTRACT
Background:
Bioactive compounds, such as human milk oligosaccharides (HMOs), impact the development of the intestinal microbiome and immune maturation in early life. They have shown to result in positive benefits including improved gut health, reduced frequency of infections, and age-appropriate growth when added to infant formula. However, data is currently lacking among Chinese infants.
Objective:
In this double-blind randomized controlled trial including a non-randomized reference breastfed group (BG), we will test the efficacy of ready to feed (RTF) infant formula containing 2 HMOs (2-fucosyllactose [2’FL] and lacto-N-neotetraose [LNnT]) on Bifidobacteria abundance, gut microbiome, gut and immune health, growth, and quality of life.
Methods:
Healthy infants will be enrolled between 3 and 14 days after birth across 4 sites and randomized to the experimental group (EG, fed RTF infant formula containing 2 HMOs) or control group (CG, fed the same RTF infant formula without the 2 HMOs) using a dynamic allocation algorithm with double blinding. Infants will receive trial formula until 6 months of age and be followed up until 12 months of age. The BG group will serve as a reference. The primary endpoint will be Bifidobacteria abundance in fecal samples at 3 months. Secondary endpoints will include fecal microbiome, fecal markers of immune health, GI tolerance, stooling patterns, immune competence (overall state of immune system), sleep quality, growth, quality of life, medication use, and physician reported adverse events (AEs). A two-sided test at the 5% significance level will be used for statistical testing.
Results:
The STARLIT trial has been initiated in July 2024 and is currently underway. As of September 2024, four infants have been enrolled. The recruitment is expected to be completed in 2025 and study results available in 2026.
Conclusions:
The “STARLIT” trial will be one of the first to assess the efficacy of these two HMOs among Chinese infants on gut and immune health in addition to clinically relevant outcomes such as quality of life, growth, and AE. We hypothesize an increase in the growth of beneficial Bifidobacteria in response to intake of 2’FL and LNnT that may have a broader impact on overall infant gut and immune health. Clinical Trial: NCT06361719
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