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

Marlene W. Borschel, Dean L. Antonson, Nancy D. Murray, Maria Oliva-Hemker, Lynn E. Mattis, Benny Kerzner, Vasundhara Tolia, Geraldine Baggs

Research output: Contribution to journalArticle

Abstract

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).

Original languageEnglish (US)
Article number136
JournalBMC Pediatrics
Volume14
Issue number1
DOIs
StatePublished - May 29 2014

Fingerprint

Diarrhea
Amino Acids
Parenteral Nutrition
Short Bowel Syndrome
Weights and Measures
Specialized Foods
Physicians
Nutritional Requirements
Food Hypersensitivity
Growth and Development
Weight Gain
Food
Growth

Keywords

  • Chronic diarrhea
  • Elemental formula
  • Eosinophilic gastroenteritis
  • Food allergy
  • Free amino acid-based formula
  • Gastroesophageal reflux
  • Hypoallergenic
  • Inflammatory bowel disease
  • Malabsorption
  • Short bowel syndrome

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Medicine(all)

Cite this

Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. / Borschel, Marlene W.; Antonson, Dean L.; Murray, Nancy D.; Oliva-Hemker, Maria; Mattis, Lynn E.; Kerzner, Benny; Tolia, Vasundhara; Baggs, Geraldine.

In: BMC Pediatrics, Vol. 14, No. 1, 136, 29.05.2014.

Research output: Contribution to journalArticle

Borschel, Marlene W. ; Antonson, Dean L. ; Murray, Nancy D. ; Oliva-Hemker, Maria ; Mattis, Lynn E. ; Kerzner, Benny ; Tolia, Vasundhara ; Baggs, Geraldine. / Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. In: BMC Pediatrics. 2014 ; Vol. 14, No. 1.
@article{12bc0e7f4e194e1aaba15332073cc30e,
title = "Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula",
abstract = "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).",
keywords = "Chronic diarrhea, Elemental formula, Eosinophilic gastroenteritis, Food allergy, Free amino acid-based formula, Gastroesophageal reflux, Hypoallergenic, Inflammatory bowel disease, Malabsorption, Short bowel syndrome",
author = "Borschel, {Marlene W.} and Antonson, {Dean L.} and Murray, {Nancy D.} and Maria Oliva-Hemker and Mattis, {Lynn E.} and Benny Kerzner and Vasundhara Tolia and Geraldine Baggs",
year = "2014",
month = "5",
day = "29",
doi = "10.1186/1471-2431-14-136",
language = "English (US)",
volume = "14",
journal = "BMC Pediatrics",
issn = "1471-2431",
publisher = "BioMed Central",
number = "1",

}

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

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

UR - http://www.scopus.com/inward/record.url?scp=84902536798&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84902536798&partnerID=8YFLogxK

U2 - 10.1186/1471-2431-14-136

DO - 10.1186/1471-2431-14-136

M3 - Article

VL - 14

JO - BMC Pediatrics

JF - BMC Pediatrics

SN - 1471-2431

IS - 1

M1 - 136

ER -