A Thickened Amino-Acid Formula in Infants with Cow’s Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: A Randomized Double-Blind Trial

Dupont, Christophe; Kalach, Nicolas; Soulaines, Pascale; Bradatan, E.; Lachaux, Alain; Payot, F.; Blay, F. De; Guénard-Bilbault, Lydie; Hatahet, R; Mulier, Sandra

doi:10.1007/s40272-014-0097-x

Cited by 15 publications

(24 citation statements)

References 47 publications

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“…28 Similar data were published for the AAF Sineall (Humana, Milan, Italy) 29 and Novalac (United Pharmaceuticals, Paris, France). 30,31 All these studies used Neocate as a validated reference product in diagnostic challenges and/ or in the treatment phases. Many other AAF formulations are commercially available worldwide, only a minority of which have been studied for hypoallergenicity.…”

Section: Discussionmentioning

confidence: 99%

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A well‐tolerated new amino acid–based formula for cow's milk allergy

Fierro

Valluzzi

Baratto

et al. 2020

Immunity Inflam & Disease

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Objectives: Infants with cow's milk allergy (CMA) are in need of a substitute formula up to 2 years. The are three requisites for a substitute of milk in CMA: tolerability, nutritional adequacy, and cost-effectiveness. We evaluate here the tolerability of a new amino acid-based infant formula for the management of CMA. Methods: In a phase III/IV prospective, multicentre, open-label, international study, infants and children with immunoglobulin E-mediated CMA were exposed to a diagnostic double-blinded, placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo. If tolerant to it, the study formula was integrated into the patients' usual daily diet for 7 days. Efficacy on day 7 was assessed in terms of symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data. Results: Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years) completed the open challenge and were able to consume the study formula for at least 7 days. No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%. Sixteen patient under the age of two continued with the optional extension phase. Conclusions: The study formula meets the American Academy of Pediatric criteria for hypoallergenicity and is well tolerated in short-term use. During optional phase, growth of the patients was not hindered by the study formula.

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Section: Discussionmentioning

confidence: 99%

“…They are also indicated in case of allergic reaction to eHF. Unlike similar studies 30,31 we did not select children with severe forms of CMA allergic to eHFs, which is a clear limitation. Another limitation of our study is the lack of a control group, fed an eHF or a different AAF.…”

Section: Discussionmentioning

confidence: 99%

A well‐tolerated new amino acid–based formula for cow's milk allergy

Fierro

Valluzzi

Baratto

et al. 2020

Immunity Inflam & Disease

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“…In another study, data suggested that hypoallergenic (AAFs) formulas improved the gut barrier function and minimized gastrointestinal complications in atopic infants (14). Similarly, when fed an AAF, infants with CMPA with multiple food allergies demonstrated reduced allergic symptoms and normal growth (15,21,22). The results in the present study indicated that longer-term feeding of an AAF in infants with poorly managed CMPA, improved long-term allergy management.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of an Amino Acid−Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula

Vanderhoof

Moore

Boissieu

2016

J. pediatr. gastroenterol. nutr.

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“…Furthermore, in a prospective, multicentre, double-blind randomised control trial (Dupont et al, 2014(Dupont et al, , 2015, the addition of pectin (0.5 g/100 mL) to amino-acid based formulae (thickened aminoacid-based formula (TAAF)) for children (n = 75) allergic to cow's milk and intolerant to extensively hydrolysed milk proteins, was studied. A commercially available 'reference' amino-acid based formula (RAAF) served as a reference.…”

Section: Studies In Infantsmentioning

confidence: 99%

Re‐evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives

Mortensen¹,

Aguilar²,

Crebelli³

et al. 2017

EFS2

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Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives. An acceptable daily intake (ADI) 'not specified' was allocated by the Scientific Committee for Food (SCF) for E 440i and E 440ii. Pectin and amidated pectin would not be absorbed intact, but extensively fermented by intestinal microbiota in animals and humans; products formed from pectins in the gastrointestinal tract are similar to manufactured pectin-derived acidic oligosaccharides (pAOS). There is no indication of genotoxicity for pectin and amidated pectin, although the available data were limited. No adverse effects were reported in a chronic toxicity study in rats at levels up to 5,000 mg pectin/kg bw per day, the highest dose tested. No treatment-related effects were observed in a dietary one-generation reproductive toxicity study with pAOS in rats at up to 6,200 mg/kg body weight (bw) per day, the highest dose tested. The Panel did not consider E 440i and E 440ii as having allergenic potential. A dose of 36 g/day (equivalent to 515 mg/kg bw per day) for 6 weeks in humans was without adverse effects. Exposure to pectins from their use as food additives ranged up to 442 mg/kg bw per day for toddlers at the 95th percentile (brand-loyal scenario). The Panel concluded that there is no safety concern for the use of pectin (E 440i) and amidated pectin (E 440ii) as food additives for the general population and that there is no need for a numerical ADI.

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A Thickened Amino-Acid Formula in Infants with Cow’s Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: A Randomized Double-Blind Trial

Abstract: Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.

Cited by 15 publications

References 47 publications

A well‐tolerated new amino acid–based formula for cow's milk allergy

A well‐tolerated new amino acid–based formula for cow's milk allergy

Evaluation of an Amino Acid−Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula

Re‐evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives

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