Trial reportAllergy2016
Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a randomized controlled trial.
Trial report in Allergy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 4 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
41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- The Effects of Prebiotics, Synbiotics, and Short-Chain Fatty Acids on Respiratory Tract Infections and Immune Function: A Systematic Review and Meta-Analysis.Advances in nutrition (Bethesda, Md.) · 2022Pooled it
- Infant formulas containing hydrolysed protein for prevention of allergic disease.The Cochrane database of systematic reviews · 2018Pooled it
- WITHDRAWN: Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy.The Cochrane database of systematic reviews · 2017Pooled it
- Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy.The Cochrane database of systematic reviews · 2017Pooled it
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- Philippine guidelines on the dietary primary prevention of allergic diseases in children.Asia Pacific allergy · 2024Review
- Tailored recommendations for infant milk formula intake results in more accurate feeding.European journal of pediatrics · 2024Article
- The Effect of Prebiotics on Atopic Dermatitis.Allergy, asthma & immunology research · 2023Article
- Pre-, pro-, syn-, and Postbiotics in Infant Formulas: What Are the Immune Benefits for Infants?Nutrients · 2023Review
- The use of hydrolyzed formulas as a method of correction of feeding and clinical rehabilitation of infants with atopy signs.Journal of medicine and life · 2022Article
- Review
- Article
- Manipulating Microbiota to Treat Atopic Dermatitis: Functions and Therapies.Pathogens (Basel, Switzerland) · 2022Review
- Early Life and Nutrition and Allergy Development.Nutrients · 2022Article
- S3 guideline Allergy Prevention.Allergologie select · 2022Article
- Nutritional Interventions to Prevent the Development of Atopic Diseases: A Focus on Cow's Milk Allergy.Handbook of experimental pharmacology · 2022Article
- Microbiome Modulation as a Therapeutic Approach in Chronic Skin Diseases.Biomedicines · 2021Review
- Control of lymphocyte functions by gut microbiota-derived short-chain fatty acids.Cellular & molecular immunology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 11 institutions in 5 countries.
Funding
Abstract
backgroundPrevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes.
objectiveTo evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597].
methodsWe conducted a parallel-group, multicentre, randomized double-blind controlled trial of pHF-OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0-4 weeks (375 pHF-OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events.
resultsEczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF-OS at 0-4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF-OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF-OS did not change most immune markers including total/specific IgE; however, pHF-OS reduced cow's milk-specific IgG1 (P < 0.0001) and increased regulatory T-cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events.
conclusionpHF-OS does not prevent eczema in the first year in high-risk infants. The immunological changes found require confirmation in a separate cohort.
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