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.
  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.
  
  
  BACKGROUND
  Both trials were registered on ClinTrials.gov (CD-C, NCT01812629; CD-I, NCT01820494).
authors.affiliation: Scientific & Medical Affairs, Abbott Nutrition, Abbott Laboratories, 3300 Stelzer Road, Columbus, Ohio 43219, USA. marlene.borschel@abbott.com.
authors.forename: Marlene W
authors.initials: MW
authors.lastname: Borschel
authors.forename: Dean L
authors.initials: DL
authors.lastname: Antonson
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Murray
authors.forename: Maria
authors.initials: M
authors.lastname: Oliva-Hemker
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Mattis
authors.forename: Benny
authors.initials: B
authors.lastname: Kerzner
authors.forename: Vasundhara
authors.initials: V
authors.lastname: Tolia
authors.forename: Geraldine
authors.initials: G
authors.lastname: Baggs
mesh_terms: D000469:Alkaline Phosphatase / Q000097:blood; D000596:Amino Acids / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D003967:Diarrhea / Q000628:therapy*; D002149:Energy Intake; D005260:Female; D005526:Food, Formulated; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D015430:Weight Gain
chemical_list: D000596:Amino Acids; D000469:Alkaline Phosphatase