Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula

Abstract

BackgroundInfants and children with chronic diarrhea (CD) often require specialized foods or parenteral nutrition (PN) to achieve adequate nutrient intakes to support growth and development. We assessed the efficacy of an amino acid-based formula (AAF) in supporting growth and improving symptoms in infants and children with CD from multiple etiologies.MethodsTwo studies were conducted: CD study in children (CD-C) and CD study in infants (CD-I). Each was a single group, baseline-controlled study in which each subject served as his/her own control. At enrollment, all subjects had CD lasting > 2 weeks and had ≥ 4 stools/day. Subjects were fed an AAF for 80 days starting at SD5, and were assessed at SD 28 and 84.ResultsCD-C: 18 of 19 subjects completed the study. At enrollment, the mean age was 5.6 ± 0.7 years, the most common diagnosis was short bowel syndrome (SBS) (n = 13), and 5 subjects with SBS were on PN. Subjects achieved significant increases in weight-for-age z-scores (p = 0.026). Over 50% of subjects achieved improvements in clinical outcomes targeted most frequently by their physicians. Of the five subjects on PN at enrollment, four had substantial weight gain and four had their PN requirements decreased. CD-I: 22 of 27 subjects completed the study. At enrollment, the mean age was 3.3 ± 0.3 months, the most common diagnosis was food allergy (n = 20), and no subjects were on PN. Subjects achieved significant increases in weight-for-age z-scores (p = 0.0023), significant decreases in the number of stools/day (p = 0.0012), and improvements in stool consistency (p = 0.0024). Over 80% of subjects achieved improvements in the clinical outcomes targeted most frequently by their physicians.ConclusionsInfants and children with CD fed an AAF for three months displayed significant improvements in weight-for-age z-scores and clinical symptoms. Children dependent on PN also grew well and four of five decreased their dependence on PN.Trial registrationBoth trials were registered on ClinTrials.gov (CD-C, NCT01812629; CD-I, NCT01820494).

Comparison of Growth of Healthy Term Infants Fed Extensively Hydrolyzed Protein- and Amino Acid-Based Infant Formulas

“…The degree to which poorly growing patients placed on an EHF or AAF might be impacted by these data obtained in healthy term infants can only be speculated. However, in a study in compromised children [ 31 ], AAF-E was substituted isocalorically for the child’s pre-study formula for 80 days. Once receiving formula AAF-E, WHO weight-for-age z -scores of children increased significantly over the study period ( p = 0.0260).…”

“…Once receiving formula AAF-E, WHO weight-for-age z -scores of children increased significantly over the study period ( p = 0.0260). Mean weight gains were 7 ± 2 g/day in the 90-days prior to study entry increasing to 19 ± 7 g/day during the study period ( p = 0.0545) [ 31 ]. Of the 19 subjects, the pre-study formula feeding was AAF-F (previous US version without added MCT) in 5, an up-age version of AAF-F in 1, EHF-C in 4, and a modular EHF similar to EHF-C, but with 85% of fat from MCT (3232A, Mead Johnson Nutritionals) in 2.…”

Amino acid formulas in patients with food allergy

“…Продемонстрировано влияние на ростовые значения таких цитокинов, как IL 6, продуцируемый макрофагами, и фактор некроза опухоли α (TNF-α), при различных патологиях [23]. Так как у здоровых детей различий в изменении массо-ростовых показателей при использовании АКС или ВГС отмечено не было, вероятнее всего, патофизиологические изменения связаны с барьерной функцией кишечника и сохраняющимся воспалением при применении ВГС [52,53].…”

Illuminating Elimination Diets: Controversies Regarding Dietary Treatment of Eosinophilic Esophagitis

“…41 Elemental formulas consist only of free amino acids, corn syrup solids, and vegetable oils, components that are innately hypoallergenic. 42,43 It was this therapy, in a landmark study by Kelly and colleagues of children with severe esophageal eosinophilia and GI symptoms despite high-dose PPI treatment, that provided the first clinical evidence that complete food allergen avoidance successfully treated EoE. 21 Subsequent to this, additional studies showed that elemental formula-based diets were highly efficacious (85 -95% response rates) for reducing inflammation and improving symptoms of EoE in patients of all ages.…”