TY - JOUR
T1 - Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula
AU - Borschel, Marlene W.
AU - Antonson, Dean L.
AU - Murray, Nancy D.
AU - Oliva-Hemker, Maria
AU - Mattis, Lynn E.
AU - Kerzner, Benny
AU - Tolia, Vasundhara
AU - Baggs, Geraldine
N1 - Funding Information:
The studies reported were supported by Abbott Nutrition (AN), Abbott Laboratories, Columbus, Ohio. AN, with the assistance and input of the investigators, designed the studies and interpreted the results. AN monitored the collection of data and completed the statistical analyses. The authors appreciate the assistance of Jane Carver, PhD, who provided medical writing services on behalf of AN, Abbott Laboratories.
Funding Information:
MWB and GEB are employees of Abbott Nutrition, Abbott Laboratories. MO-H has received research funding from Abbott Immunology.
PY - 2014/5/29
Y1 - 2014/5/29
N2 - Background: Infants 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.Methods: Two 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.Results: CD-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.Conclusions: Infants 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 registration: Both trials were registered on ClinTrials.gov (CD-C, NCT01812629; CD-I, NCT01820494).
AB - Background: Infants 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.Methods: Two 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.Results: CD-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.Conclusions: Infants 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 registration: Both trials were registered on ClinTrials.gov (CD-C, NCT01812629; CD-I, NCT01820494).
KW - Chronic diarrhea
KW - Elemental formula
KW - Eosinophilic gastroenteritis
KW - Food allergy
KW - Free amino acid-based formula
KW - Gastroesophageal reflux
KW - Hypoallergenic
KW - Inflammatory bowel disease
KW - Malabsorption
KW - Short bowel syndrome
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U2 - 10.1186/1471-2431-14-136
DO - 10.1186/1471-2431-14-136
M3 - Article
C2 - 24885833
AN - SCOPUS:84902536798
SN - 1471-2431
VL - 14
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 136
ER -