Trial reportNutrients2022
Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow's Milk Protein Allergy: A Randomized, Multi-Center Trial.
Trial report in Nutrients, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 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.
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)
Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effects of probiotics, prebiotics, synbiotics and postbiotics on pediatric asthma: a systematic review.Frontiers in nutrition · 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
- From Diet to Dysbiosis: How Nutritional Factors Shape Gut Microbiota and Drive Airway Inflammation in Pediatric Asthma.Nutrients · 2026Review
- The Impact of Milk Protein Allergy on Pediatric Otitis Media Incidence.The Laryngoscope · 2026Article
- Limited Evidence of Benefits from Clinical Trials of Human-Identical Milk Oligosaccharides for Infants.Advances in nutrition (Bethesda, Md.) · 2026Review
- Hypoallergenicity of a hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose in children with cow's milk allergy: protocol for a randomized controlled study. The RIGHT-HY study.Frontiers in nutrition · 2026Article
- The gut-lung axis in childhood asthma: from early-life programming to microbiome-informed precision medicine-a narrative review.Frontiers in immunology · 2026Review
- Growth and safety of infants with cow's milk allergy receiving a new hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose: protocol for a randomized clinical trial. The RIGHT-GO study.Frontiers in nutrition · 2026Article
- 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.JMIR research protocols · 2025Article
- Comparative Analysis of Breastfeeding and Infant Formulas: Short- and Long-Term Impacts on Infant Nutrition and Health.Food science & nutrition · 2025Review
- In Vivo Evidence on the Emerging Potential of Non-Digestible Oligosaccharides as Therapeutic Agents in Bacterial and Viral Infections.Nutrients · 2025Review
- 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
- Clinical evidence and mechanistic pathways of human milk oligosaccharide supplementation for health benefits: an updated review.Frontiers in nutrition · 2025Review
- 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
- Advancements in Non-Thermal Processing Technologies for Enhancing Safety and Quality of Infant and Baby Food Products: A Review.Foods (Basel, Switzerland) · 2024Review
- Biological effects of combinations of structurally diverse human milk oligosaccharides.Frontiers in pediatrics · 2024Review
- Prebiotics in New-Born and Children's Health.Microorganisms · 2023Review
- The Link between Different Types of Prebiotics in Infant Formula and Infection Rates: A Review.Nutrients · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
This randomized clinical trial (Registration: NCT03085134) assessed if an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) and reduced protein content (2.20 g/100 kcal) supports normal growth in infants with cow’s milk protein allergy (CMPA). Secondary outcomes were gastrointestinal tolerability, safety, and effect on infections. Nonbreastfed infants aged 0−6 months with CMPA were enrolled. Body weight, length, and head circumference were measured monthly for 4 months (primary study endpoint), after 6 months, and at the age of 12 months. Of 200 infants screened, 194 (mean age 3.2 months) were randomized. At the 4-month follow-up, daily weight gain for the test formula was noninferior to the control formula; p < 0.005. There were no significant group differences in anthropometric parameters. Both formulas were safe and well tolerated. Infants in the HMO group had a statistically significant reduction in the frequency of upper respiratory tract infections and a lower incidence of ear infections at 12 months (per protocol analysis). The relative risk of lower respiratory tract and gastrointestinal infections was reduced by 30−40%, but this was not statistically significant due to sample size limitations. In summary, the HMO-supplemented formula supports normal growth in infants with CMPA and suggests a protective effect against respiratory and ear infections in the first year of life.
Indexed as
Identifiers
What OpenQuestion holds
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.