Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial
Bibliographic record
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 been 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: In this double-blind randomized controlled trial including a nonrandomized reference breastfed group, we will test the efficacy of ready-to-feed infant formula containing 2 HMOs (2-fucosyllactose and lacto-N-neotetraose) 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 at 5 sites in China and randomized to either the experimental group (fed ready-to-feed infant formula containing 2 HMOs) or the control group (fed the same ready-to-feed infant formula without the 2 HMOs), using a dynamic allocation algorithm with double blinding. Infants will receive trial formula until age 6 months and will be followed up until age 12 months. The breastfed group will serve as a reference. The primary end point will be Bifidobacteria abundance in fecal samples at 3 months, measured via quantitative polymerase chain reaction. Secondary end points will include fecal microbiome (including taxonomy, diversity, functionality, and metabolites), fecal markers of immune health, gastrointestinal tolerance, stooling patterns, immune competence (overall state of the immune system), sleep quality, growth, quality of life, medication use, and physician-reported adverse events. A 2-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 Starter Liquid Infant Formula Trial (STARLIT) will be one of the first to assess the efficacy of these 2 HMOs among Chinese infants on gut and immune health, in addition to clinically relevant outcomes such as quality of life, growth, and adverse events. This study should help to demonstrate that an increase in the growth of beneficial Bifidobacteria in response to intake of 2-fucosyllactose and lacto-N-neotetraose may have a broader impact on overall gut microbiome composition and infant gut and immune health. TRIAL REGISTRATION: ClinicalTrials.gov NCT06361719; https://clinicaltrials.gov/study/NCT06361719. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/66489.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.012 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.028 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".