Trial reportBMC pediatrics2015
Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial.
Trial report in BMC pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01122654 (Growth and Tolerance of Cow Milk-Based Infant Formulas), which is not on this map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Growth and Tolerance of Cow Milk-Based Infant Formulas
Who cites it
21 citing papers in PubMed, 48 citations in OpenAlex.
- Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT.BMC pediatrics · 2026Trial
- Evaluation of Bovine Lactoferrin for Prevention of Late-Onset Sepsis in Low-Birth-Weight Infants: A Double-Blind Randomized Controlled Trial.Nutrients · 2025Trial
- New infant formulas for healthy term infants: A randomized, controlled, double-blind, multicenter, non-inferiority design safety study.PloS one · 2025Trial
- Trial
- Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial.BMC pediatrics · 2021Trial
- Developmental effects on sleep-wake patterns in infants receiving a cow's milk-based infant formula with an added prebiotic blend: a Randomized Controlled Trial.Pediatric research · 2021Trial
- Trial
- Associations of human milk lactoferrin with measures of physical growth in very preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- A Randomized Controlled Trial of a Partially Hydrolyzed Formula on Comfort Measures in Fussy Infants.Current developments in nutrition · 2025Article
- Nutraceutical and Health-Promoting Potential of Lactoferrin, an Iron-Binding Protein in Human and Animal: Current Knowledge.Biological trace element research · 2024Review
- Clinical research review: usefulness of bovine lactoferrin in child health.Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2023Review
- Effect of lactoferrin in oral nutrition supplement (ONS) towards IL-6 and IL-10 in failure to thrive children with infection.F1000Research · 2023Article
- The Lactoferrin Phenomenon-A Miracle Molecule.Molecules (Basel, Switzerland) · 2022Review
- Lactoferrin: Cytokine Modulation and Application in Clinical Practice.Journal of clinical medicine · 2021Review
- Development of Visceral and Subcutaneous-Abdominal Adipose Tissue in Breastfed Infants during First Year of Lactation.Nutrients · 2021Article
- Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review.Biomedicines · 2021Review
- Human milk immunomodulatory proteins are related to development of infant body composition during the first year of lactation.Pediatric research · 2021Observational
- Role of Human Milk Bioactives on Infants' Gut and Immune Health.Frontiers in immunology · 2021Review
- Bioactive Compounds in Infant Formula and Their Effects on Infant Nutrition and Health: A Systematic Literature Review.International journal of food science · 2021Review
- Synergistic Killing of Pathogenic Escherichia coli Using Camel Lactoferrin from Different Saudi Camel Clans and Various Antibiotics.The protein journal · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHuman milk provides necessary macronutrients (protein, carbohydrate, fat) required for infant nutrition. Lactoferrin (Lf), a multifunctional iron-binding protein predominant in human milk, shares similar protein sequence, structure, and bioactivity with bovine Lf (bLf). This large-scale pediatric nutrition study was designed to evaluate growth and tolerance in healthy infants who received study formulas with bLf at concentrations within the range of mature human milk.
methodsIn this multi-center, double-blind, parallel-designed, gender-stratified prospective study 480 infants were randomized to receive a marketed routine cow's milk-based infant formula (Control; n = 155) or one of two investigational formulas with bLf at 0.6 g/L (LF-0.6; n = 165) or 1.0 g/L (LF-1.0; n = 160) from 14-365 days of age. Investigational formulas also had a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) and adjusted arachidonic acid (ARA). The primary outcome was weight growth rate from 14-120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, 120, 180, 275, and 365 days of age. Parental recall of formula intake, tolerance, and stool characteristics was collected at each time point. Medically-confirmed adverse events were collected throughout the study period.
resultsThere were no group differences in growth rate (g/day) from 14-120 days of age; 353 infants completed the study through 365 days of age ( CONTROL: 110; LF-0.6: 127; LF-1.0: 116). Few differences in growth, formula intake, and infant fussiness or gassiness were observed through 365 day of age. Group discontinuation rates and the overall group incidence of medically-confirmed adverse events were not significantly different. From 30 through 180 days of age, group differences in stool consistency (P < 0.005) were detected with softer stools for infants in the LF-0.6 and LF-1.0 groups versus CONTROL.
conclusionCompared to the Control, infants who received investigational formulas with bLf and the prebiotic blend of PDX and GOS experienced a softer stooling pattern similar to that reported in breastfed infants. This study demonstrated routine infant formulas with bLf, a blend of PDX and GOS, and adjusted ARA were safe, well-tolerated, and associated with normal growth when fed to healthy term infants through 365 days of age.
trial registrationClinicalTrials.gov NCT01122654 . Registered 10 May 2010.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.