Trial reportBMC pediatrics2016
Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula.
Trial report in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02351531 (Cow Milk Allergy), which is not on this map. Cited by 13 papers.
What it found
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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.
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Who cites it
13 citing papers in PubMed, 40 citations in OpenAlex.
- Factors Associated with Anthropometry Z-Scores in Exclusively Breastfed Infants Aged 0-6 Months in 10 Cities of China.Nutrients · 2025Article
- Re-evaluation of xanthan gum (E 415) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups.EFSA journal. European Food Safety Authority · 2023Article
- Dietary fiber pectin: challenges and potential anti-inflammatory benefits for preterms and newborns.Frontiers in nutrition · 2023Review
- Growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula in infants with cow's milk protein allergy.Frontiers in pediatrics · 2023Article
- Review
- The Cow's Milk-Related Symptom Score (CoMiSSNutrients · 2022Review
- Hydrolysed Formulas in the Management of Cow's Milk Allergy: New Insights, Pitfalls and Tips.Nutrients · 2021Review
- Retrospective and Prospective Determination of the Cow's Milk-Related Symptom Score (CoMiSS™) Values in Symptomatic Infants.Pediatric gastroenterology, hepatology & nutrition · 2021Article
- Opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow-up of their re-evaluation as food additives for uses in foods for all population groups.EFSA journal. European Food Safety Authority · 2021Article
- Testing the Cow's Milk-Related Symptom Score (CoMiSSNutrients · 2019Article
- Hypoallergenicity of a thickened hydrolyzed formula in children with cow's milk allergy.World journal of clinical cases · 2019Article
- Anti-inflammatory activity of extensively hydrolyzed casein is mediated by granzyme B.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2019Article
- Article
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 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn case of cow's milk allergy (CMA), pediatric guidelines recommend for children the use of extensively hydrolyzed formulas (eHFs) as elimination diet. According to the American Academy of Pediatrics, the hypoallergenicity of each specific eHF should be tested in subjects with CMA.
methodsA prospective, multicenter trial was performed to assess the tolerance/hypoallergenicity of a thickened casein-based eHF (eHCF, Allernova AR®, United Pharmaceuticals, France) in infants aged <12 months with CMA proven by a double-blind placebo-controlled food challenge. Its efficacy, measured through allergy symptoms monitoring and Cow's Milk-related Symptom Score (CoMiSS) calculation, and safety were evaluated during a 4-month feeding period. Growth z-scores were computed based on WHO anthropometric data.
resultsThirty infants (mean age: 4.8 ± 3.0 months) with CMA proven by a DBPCFC tolerated the eHCF during the 4-month study. The CoMiSS, crying and regurgitation scores significantly decreased by 4.2 ± 4.0, 0.9 ±1.2 and 0.7 ± 1.1 respectively, after 14 days of feeding (p < 0.001). The Scoring Atopic Dermatitis index, of 33.2 ± 14.8 at inclusion in 9 patients, significantly decreased by 15.5 ± 6.7 and 21.1 ± 11.2, after 14 and 45 days of feeding, respectively (p < 0.001). The percentage of infants having normal stool consistency (soft or formed stools) significantly improved from 66.7 % (20/30) at inclusion to 90.0 % (27/30) after 14 days of feeding (p = 0.020). The growth z-scores, negative at study inclusion, significantly improved over the 4-month study. No adverse event was related to the eHCF.
conclusionThe thickened eHCF was tolerated by more than 90 % of included allergic infants with 95 % confidence interval and can therefore be considered as hypoallergenic in accordance with current guidelines. The improvement of growth indices and absence of related adverse events confirmed its safety. Results of this trial back the use of the tested thickened eHCF as an efficient and safe alternative in children with CMA.
trial registrationClinicalTrials.gov, number NCT02351531 , registered on 27 January 2015.
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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.