JMIR Publications

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 supporting the added value of including these HMOs in early stage infant formula is currently lacking among Chinese infants.

Objective:

Hence, 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 5 sites in China 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 measured via qPCR. Secondary endpoints will include fecal microbiome (including taxonomy, diversity, functionality and metabolites), 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 study received ethical approval in March 2024 and will be completed by the end of 2026 which will be followed by a publication in a peer-reviewed journal.

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. This study should help to demonstrate that 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 gut microbiome composition and infant gut and immune health. Clinical Trial: NCT06361719