title: Gastrointestinal tolerance of a pediatric fiber formula in developmentally disabled children.
abstract: OBJECTIVE
  We performed a masked, randomized, 2-month crossover study with developmentally disabled children to study the tolerance of a pediatric adapted enteral formula with added soy fiber.
  
  
  METHODS
  Twenty children and adolescents aged 1 to 17 years, requiring liquid nutrition, were fed Pediasure (PS) and Pediasure with approximately 10 g total dietary fiber/l, (PSF10) as their major source of energy and nutrient intake for 1 month each. During the two 4-week periods of the crossover study, intake, tolerance of the formula, and stool characteristics were monitored daily with diaries. Criteria for gastrointestinal tolerance were symptoms of emesis, gas, irritability or fussiness. Stool characteristics included frequency, consistency, and the need to use elimination aids to induce defecation. Following completion of the crossover study, the patients were fed PSF10 for an additional 2 months. Anthropometrics were obtained at study initiation and at each biweekly visit during the crossover phase and monthly during the follow-up phase. Bowel scintigraphy studies were conducted in patients with oral or nasogastric intake during the crossover periods. Biochemical assessments were conducted at entry, at the end of each crossover period, and at exit.
  
  
  RESULTS
  There were no differences in any of the tolerance, stooling, growth, or biochemical measurements between the feeding regimens, in 11 children completing this phase of the study. However, there was a trend towards using less elimination aids to induce a bowel movement during the fiber supplemented formula phase.
  
  
  CONCLUSIONS
  Pediasure with fiber is well tolerated in children with developmental disabilities.
authors.affiliation: Division of Gastroenterology and Nutrition, Children's Hospital of Michigan, Wayne State University, Detroit, USA.
authors.forename: V
authors.initials: V
authors.lastname: Tolia
authors.forename: J
authors.initials: J
authors.lastname: Ventimiglia
authors.forename: L
authors.initials: L
authors.lastname: Kuhns
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003672:Defecation; D002658:Developmental Disabilities / Q000150:complications / Q000503:physiopathology; D004043:Dietary Fiber / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004750:Enteral Nutrition; D005260:Female; D005526:Food, Formulated / Q000009:adverse effects; D005746:Gastric Emptying; D006801:Humans; D007223:Infant; D008607:Intellectual Disability / Q000150:complications / Q000503:physiopathology; D008297:Male; D013025:Glycine max