Tolerance of an enteral formula with insoluble and prebiotic fiber in children with compromised gastrointestinal function.

The effects of adding fiber to the tolerance of a peptide-based formula have not been studied. The objective of this study was to evaluate the tolerance of a peptide-based formula with insoluble and prebiotic fiber in children with compromised gut function. During January 2005 to June 2006, a 6-week randomized, double-blind, cross-over clinical study was conducted to compare stool frequency, stool consistency, and tolerance (abdominal pain, abdominal distension, vomiting, weight gain, and intake) between a formula with or without 3.5 g fructo-oligosaccharides and 3.8 g insoluble fiber/L. Fourteen children with gastrointestinal dysmotility (n=9), Crohn's disease (n=3), or mild short bowel syndrome (n=2) were randomized to receive one of two formulas for 2 weeks followed by a 5-day washout period and then the second diet for another 2 weeks. Means and standard deviations of daily stool frequency and consistency were calculated and compared using intent-to-treat analysis. Linear mixed models were applied to each outcome variable. Stool frequency did not differ by formula. Stool consistency did differ with more soft "mushy" stools (less hard stools) occurring with use of fiber (P<0.001) and more watery stools occurring with control formula (P<0.01). The extremes of stool consistency were normalized with the fiber formula. No significant differences were observed in vomiting, abdominal pain, feeding intakes, or weight gain between the two formulas. This study showed that a peptide-based formula containing fiber was as well-tolerated as a fiber-free formula in a small population of children with gastrointestinal impairments. Longer-term effects of the fiber formula need to be studied.