GASTROINTESTINAL TOLERANCE OF A PEDIATRIC FIBER FORMULA IN DEVELOPMENTALLY DISABLED-CHILDREN

Objective: We performed a masked, randomized, 2-month crossover study with developmentally disabled children to study the tolerance of a ped iatric adapted enteral formula with added soy fiber. Methods: Twenty c hildren and adolescents aged 1 to 17 years, requiring liquid nutrition , were fed Pediasure(R) (PS) and Pediasure(R) with approximately 10 g total dietary fiber/l, (PSF10) as their major source of energy and nut rient intake for 1 month each. During the two 4-week periods of the cr ossover study, intake, tolerance of the formula, and stool characteris tics were monitored daily with diaries. Criteria for gastrointestinal tolerance were symptoms of emesis, gas, irritability or fussiness. Sto ol characteristics included frequency, consistency, and the need to us e elimination aids to induce defecation. Following completion of the c rossover study, the patients were fed PSF10 for an additional 2 months . Anthropometrics were obtained at study initiation and at each biweek ly visit during the crossover phase and monthly during the follow-up p hase. Bowel scintigraphy studies were conducted in patients with oral or nasogastric intake during the crossover periods. Biochemical assess ments were conducted at entry, at the end of each crossover period, an d at exit. Results: There were no differences in any of the tolerance, stooling, growth, or biochemical measurements between the feeding reg imens, in 11 children completing this phase of the study. However, the re was a trend towards using less elimination aids to induce a bowel m ovement during the fiber supplemented formula phase. Conclusions: Pedi asure(R) with fiber is well tolerated in children with developmental d isabilities.