- Research & Development
- Clinical trials and studies
- All clinical trials and studies
All clinical trials and studies
The efficacy of Novalac formulas is evidenced in published clinical trials. Amongst them are the largest studies ever performed to date on anti-regurgitation formulas, extensively hydrolyzed formulas, and elemental (amino-acid) formulas.
Rossetti D, Cucchiara S, Morace A, Leter B, Oliva S
Allergy to cow's milk is the most frequent allergy occurring in infants and young children. The dietary management of these patients consists of the elimination of any cow's milk proteins from the diet, and for formula-fed infants, the substitution of the usual infant formula with an adapted formula that is generally based on extensively hydrolyzed cow's milk proteins.This study aims to assess the hypoallergenicity of a new thickened extensively hydrolyzed casein-based formula (TeHCF) in children with cow's milk allergy (CMA).
Benninga Marc A, MENA Infant Constipation Study Group, Vandenplas Y
The aim is to compare the effectiveness of the magnesium (Mg)-enriched formula vs. control formula in constipated infants.
Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R
In 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.
Vandenplas Y, De Greef E; ALLAR study group
Cow's milk allergy (CMA) is treated in formula-fed infants with an extensive protein hydrolysate. This study aimed to evaluate the nutritional safety of a non-thickened and thickened extensively casein hydrolyzed protein formula (NT- and T-eCHF) in infants with CMA.
Dupont C, Vandenplas Y; SONAR Study Group
Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to evaluate the efficacy of a new anti-regurgitation (AR) formula (Novalac), thickened with an innovative complex including fibres, on the daily number of regurgitations and to assess its impact on stool consistency and frequency.
Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guénard-Bilbault L, Hatahet R, Mulier S. Kapel N, Waligora-Dupriet AJ, Butel MJ
Amino acid-based formulas (AAFs) are recommended for children with cow's-milk allergy (CMA) failing to respond to extensively hydrolysed formulas (eHFs). We evaluated the effects of a new thickened AAF (TAAF, Novalac), containing a pectin-based thickener, and a reference AAF (RAAF, Neocate) on allergy symptoms and safety, through blood biochemistry analysis and growth.
Dupont C, Hol J, Nieuwenhuis EE; Cow's Milk Allergy Modified by Elimination and Lactobacilli study group
Children with cows' milk protein allergy (CMPA) are at risk of insufficient length and weight gain, and the nutritional efficacy of hypo-allergenic formulas should be carefully assessed. In 2008, a trial assessed the impact of probiotic supplementation of an extensively hydrolysed casein-based formula (eHCF) on acquisition of tolerance in 119 infants with CMPA. First analysis of the study results showed that the studied formula allowed improvement of food-related symptoms. The scoring of atopic dermatitis (SCORAD) index was assessed at randomisation and after 6 months of feeding. A post hoc analysis was performed using WHO growth software's nutritional survey module (WHO Anthro version 3.2.2). All infants who were fed the study formula tolerated it well. The SCORAD index significantly improved from randomisation to 6 months of feeding with the study formula. Anthropometric data indicated a significant improvement in the weight-for-age, length-for-age and weight-for-length z scores, as well as in the restoration of normal BMI. The probiotic supplementation did not show any impact on these parameters. The present data showed that this eHCF was clinically tolerated and significantly improved the SCORAD index and growth indices.
Vandenplas Y, De Greef E, Hauser B; Paradice Study Group
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.
Carlos I. Oyervides, Isabel Torres, Alma R. Paredes, Gastroenterologia, Hospital del Niño "Federico Gómez", Saltillo, Mexico
Background: Diarrheal diseases are one of the most important causes of morbidity and mortality in children under 5 years of age. In the second year of life, milk continues to be essential part of a child’s diet. Providing a milk formula designed to improve its intestinal tolerability and to maintain an adequate nutritional intake, have an effect on enteral
Vandenplas Y, Leluyer B, Cazaubiel M, Housez B, Bocquet A
Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF).
Infante Pina D, Segarra O, Luyer BL
The aim is to evaluate the impact of feeding colicky infants with an adapted formula on the hydrogen breath test and clinical symptoms.
Infante DD, Segarra OO, Redecillas SS, Alvarez MM, Miserachs MM
Constipation is a common occurrence in formula-fed infants. The aim of this preliminary study was to evaluate the impact of a formula with high levels of lactose and magnesium, in compliance with the official regulations, on stool water content, as well as a parental assessment of constipation.
Vandenplas Y., Devreker Th., Hauser B
Regurgitation, irritability, and vomiting are common in infants with mid gastro-esophageal reflux disease (GERD) but are indistinguishable from regurgitation, irritability and vomiting caused by food allergy. Both conditions occur in about 5 % of infants. Thickened formula has been shown effective in the treatment of (troublesome) regurgitation and mild GERD, and an extensive hydrolysate is recommended in the treatment of cow milk allergy (CMA).
Le Luyer B, Makhoul G, Duhamel JF
In a double-blind, randomized, controlled, multicentric study, the study compared the efficacy of a specific adapted formula (lactose-free, high-mineral, low-osmolarity formula, containing rice and pectin fortified with Saccharomyces boulardii) in the management of infants with acute diarrhea with a standard formula used to feed healthy infants from birth.
Vandenplas Y, Devreker T, Hauser B
Infant regurgitation and distress are common but are a major cause of parental anxiousness. The efficacy of dietary management is contradictory.
Infante Pina D, Badia Llach X, Ariño-Armengol B, Villegas Iglesias V
The aim is to assess the prevalence of mild gastrointestinal disorders in milk-fed infants in paediatric practice, and to evaluate the effectiveness and satisfaction with dietetic treatment.
“Greedy” infants are defined subjectively, either they ingest too much daily milk or cry due to excessive hunger when the ingested volumes are limited.
At present, few studies have focused on these infants. Due to excessive meal volumes and/or the early addition of infant cereals intended to satisfy their appetite and, as a result, an excessive weight gain during the first months, this population of infants may develop into overweight adults.
In this study, the change in the casein to whey proteins ratio, quantity of lactose and lipid fraction in the composition of the formula is a modifying factor of gastric evacuation that can be used to control satiety without increasing the volume or energy density of meals for these children. Greater objectivity on weight and growth is necessary. In the meantime, this study reveals greater comfort in feeding for infants and their parents.
Chao HC, Vandenplas Y
The purpose of this study was to evaluate the efficacy of a specially selected cornstarch-supplemented formula on clinical symptoms, gastric emptying and weight gain in infants with regurgitation.
We performed a prospective randomised trial evaluating the therapeutic efficacy of two different formula feedings (cornstarch-thickened formula, group A; 25% strengthened formula, group B) in 81 young infants with regurgitation/vomiting > or = 3 times/day. A Tc-99 m milk scintigraphy was performed at inclusion and after 2 months to quantify gastric emptying time; all studied infants underwent a 2-month period of clinical follow-up evaluating regurgitation and body weight gain. At inclusion, group A and B had a similar age and weight (...).
Chao HC, Vandenplas Y
Infant constipation is a frequent condition in formula-fed infants.
A prospective randomized clinical trial was performed in infants who had constipation with Novalac-IT (IT group) versus a 20% strengthened formula (S group). Enrolled subjects had difficulties in defecating, hard stools, or low frequency of defecation (< or =3 times/wk) (...).
Terheggen-Lagro S, Khouw I, Shaafsma A, Wauters E
Formulae for infants with cow's milk protein allergy (CMA) should be based on extensively hydrolysed protein. 'Extensively' however is not strictly defined. Differences in molecular weight and peptide chain length may affect its clinical outcome. We studied the safety of a new extensively hydrolysed casein based formula (Novalac Allernova®: ALL) for children with IgE mediated CMA.
Xinias I, Mouane N, Le Luyer B, Spiroglou K, Demertzidou V, Hauser B, Vandenplas Y
Infant regurgitation is a phenomenon causing worldwide parental distress and anxiety. Parental reassurance and dietary advices regarding feeding techniques and volumes are helpful in the management. Guidelines also recommend the use of thickened formula. However, the impact of thickened feeding on the frequency of acid reflux is still a matter of debate. Therefore, we evaluated the effect of a casein predominant formula thickened with a specifically selected and treated cornstarch on the frequency and duration of acid reflux episodes.
Smarropoulos E, Liolios N, Netskos D, Anagnostopoulos D
Constipation may be early or a late complication of the surgical management, according to the Duhamel procedure, in infants affected by Hirschsprung's disease. The present study aims to assess the response of infant's gastrointestinal system towards the follow-on formula Novalac IT2. The aspect and frequency of the stools as well as the characteristics of defecation are observed in two groups of 5 infants each fed either Novalac IT2 or standard follow-on formula.
The results are impressive from the first 24 hours with the observation of soft stools in every infant fed with Novalac IT2. Novlaac IT2 promotes intestinal intraluminal osmolarity leading to normal defecations associated with minimal discomfort, as well as parents' reassurance who saw for the first time their child relieved.
Furthermore, none of the subjects fed with Novalac IT2 ever visited again the hospital because of constipation, meaning economy for both, families and medical personnel.
Girardet J-P, Palier G
The aim of the study is to evaluate the tolerance and efficiency of Novalac AD (in terms of weight recovery and diarrhea duration) during the early refeeding stage when infants stil suffer of acute diarrhea.