Dataset Information

Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy.

ABSTRACT:

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Guidelines recommend the use of extensively hydrolyzed cow's milk protein-based formulas (eHF) in the treatment of infants with cow's milk protein allergy (CMPA). Extensively hydrolyzed rice protein infant formula (eRHF) has recently become available and could offer a valid alternative. A prospective trial was performed to evaluate the hypo-allergenicity and safety of a new eRHF in infants with a confirmed CMPA. Patients were fed the study formula for 6 months. Clinical tolerance of the eRHF was evaluated with a symptom-based score (SBS) and growth (weight and length) was monitored. Forty infants (mean age, 3.4 months; range, 1-6 months) with CMPA confirmed by a food challenge were enrolled. All infants tolerated the eRHF and the SBS significantly decreased as of the first month of intervention. Moreover, the eRHF allowed a catch-up to normal weight gain as of the first month as well as a normalization of the weight-for-age, weight-for length, and BMI z-scores within the 6-month study period.

Conclusion

In accordance with current guidelines, this eRHF was tolerated by more than 90 % of children with proven CMPA with a 95 % confidence interval. This eRHF is an adequate and safe alternative to cow milk-based eHF.

SUBMITTER: Vandenplas Y

PROVIDER: S-EPMC4134482 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Publications

Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy.

Vandenplas Yvan Y De Greef Elisabeth E Hauser Bruno B

European journal of pediatrics 20140412 9

<h4>Unlabelled</h4>Guidelines recommend the use of extensively hydrolyzed cow's milk protein-based formulas (eHF) in the treatment of infants with cow's milk protein allergy (CMPA). Extensively hydrolyzed rice protein infant formula (eRHF) has recently become available and could offer a valid alternative. A prospective trial was performed to evaluate the hypo-allergenicity and safety of a new eRHF in infants with a confirmed CMPA. Patients were fed the study formula for 6 months. Clinical tolera ...[more]

PMID: 24723091

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Project description: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.

Project description:IntroductionCow's milk protein allergy (CMPA) is the most frequent food allergy in early childhood. For those infants requiring breastmilk substitutes, formulas with extensively hydrolyzed proteins (EHF), should be the treatment of choice. As there are limited data showing the progression of initial symptoms in infants newly diagnosed with CMPA who are treated with EHF with added synbiotics, the main objective of this study was to evaluate the resolution of symptoms in said infants after 4 weeks of treatment. As a secondary objective this study aimed to assess the impact of the treatment on the family's quality of life.Materials and methodsobservational, longitudinal, prospective, and multicentric real-world evidence study. The intervention phase (EHF with synbiotics) lasted 28 days and was completed by 65 patients. Treating physicians registered child´s anthropometry, Infant Gastrointestinal Symptoms Questionnaire (IGSQ-13) and CoMiSS (Cow´s Milk Allergy Symptoms Score) both at baseline and after 28 days of treatment. During treatment, caregivers reported child´s regurgitation and stools, PO-SCORAD (Patient Oriented Scoring of Atopic Dermatitis) and FAQL-PB (Family Quality of Life-Parental Burden). Data were collected using Google Forms and analyzed through the STATA program.Results95.4% of the patients showed an improvement or disappearance of the overall initial symptoms after 4 weeks of treatment. Gastrointestinal symptoms improved or disappeared in 92% of patients (p < 0.05) while dermatological symptoms improved or disappeared in 87.5% of patients (p < 0.05). The median CoMiSS at baseline was 9, with 21 patients exceeding the cut-off point of 12. After 4 weeks of treatment, the median dropped to 3, and no patient exceeded the 12-cut-off point (p = 0.000). At baseline, patients had a PO-SCORAD of 11.5 (interquartile range 1-23) that went to 1.0 (interquartile range 1-6) at day 28 (p = 0.000). The treatment diminished stool frequency (p < 0.05), improved stool consistency (p = 0.004) and decreased the frequency of regurgitation in infants with CMPA (p = 0.01). The percentage of patients who no longer had any episode of regurgitation increased from 11% to 31% on day 28 (p = 0.003). At baseline, 13% of patients cried more than 3 h per day, while at day 28 that percentage dropped to 3% (p = 0.03). An improvement in the infants' sleep pattern was also appreciated with the treatment. At study onset, 56% of the families reported feeling very overwhelmed, a percentage that dropped to 17% after 28 days of treatment (p < 0.05). The small percentage of families who did not feel overwhelmed at study onset (17%), grew to 43% on day 28 (p < 0.05).ConclusionsThe use of an EHF with synbiotics for the management of infants diagnosed with or suspected to have CMPA suggested a good safety profile, an adequate infant growth, and improvement of overall, gastrointestinal, and dermatological symptoms. It also suggested a lower daily frequency of regurgitations and stools, and an improvement in stool consistency, sleeping pattern, and quality of life of the infant and his family.

Dataset Information

Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy.

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Conclusion

Publications

Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow's milk protein allergy.

Similar Datasets

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