Trial reportNutrients2019
Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides.
Trial report in Nutrients, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Nutrition and Gut Microbiome in the Prevention of Food Allergy.Nutrients · 2025Pooled it
- Clinical Studies on the Supplementation of Manufactured Human Milk Oligosaccharides: A Systematic Review.Nutrients · 2023Pooled it
- An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and Metabolome in Infants with Cow's Milk Protein Allergy.International journal of molecular sciences · 2023Trial
- Trial
- A Comprehensive Review of Fucosylated Human Milk Oligosaccharides: Biological Functions, Production Technologies, and Safety Regulation With Commercial Translation in Infant Nutrition.Comprehensive reviews in food science and food safety · 2026Review
- From Diet to Dysbiosis: How Nutritional Factors Shape Gut Microbiota and Drive Airway Inflammation in Pediatric Asthma.Nutrients · 2026Review
- Limited Evidence of Benefits from Clinical Trials of Human-Identical Milk Oligosaccharides for Infants.Advances in nutrition (Bethesda, Md.) · 2026Review
- Article
- Clinical evidence and mechanistic pathways of human milk oligosaccharide supplementation for health benefits: an updated review.Frontiers in nutrition · 2025Review
- Bibliometric Analysis of Global Pediatric Research on Cow's Milk Protein Allergy.Journal of asthma and allergy · 2025Article
- Secretor and non-secretor human milk oligosaccharides differentially modulate immune response in the presence of cow's milk allergen β-lactoglobulin in anFrontiers in immunology · 2025Article
- Human Milk Oligosaccharides: Decoding Their Structural Variability, Health Benefits, and the Evolution of Infant Nutrition.Nutrients · 2024Review
- Tailored Combinations of Human Milk Oligosaccharides Modulate the Immune Response in an In Vitro Model of Intestinal Inflammation.Biomolecules · 2024Article
- Probiotics in the New Era of Human Milk Oligosaccharides (HMOs): HMO Utilization and Beneficial Effects ofMicroorganisms · 2024Review
- Metabolomics in Children Cow's Milk Protein Allergy: Possible Contribution from a System Biology Approach?Children (Basel, Switzerland) · 2024Review
- A comprehensive review on infant formula: nutritional and functional constituents, recent trends in processing and its impact on infants' gut microbiota.Frontiers in nutrition · 2023Review
- Review
- Biology of human milk oligosaccharides: From basic science to clinical evidence.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2022Review
- Term Infant Formulas Influencing Gut Microbiota: An Overview.Nutrients · 2021Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow's milk protein allergy (CMPA).
methodsA whey-based EHF (Test formula) containing 2'fucosyl-lactose (2'FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula.
resultsOf the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort-mean age 24.5 ± 13.6 months; range 2-57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort;
conclusionThe whey-based EHF supplemented with 2'FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.
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Registered trials
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.