Oligofructose-supplemented infant cereal: 2 randomized, blinded, community-based trials in Peruvian infants

Prebiotics are nondigestible food ingredients that stimulate the growth of Bifidobacterium and other bacteria in the gastrointestinal tract. Improved gastrointestinal and other health effects have been attributed to them. The objective of this study was to evaluate the effects of dietary supplementation with the prebiotic oligofructose with and without zinc on the prevalence of diarrhea in a community with a high burden of gastrointestinal and other infections. Two consecutive randomized, blinded, controlled clinical trials were performed in a shantytown community near Lima, Peru. The first trial compared an infant cereal supplemented with oligofructose (0.55 g/15 g cereal) with nonsupplemented cereal. During the second trial, zinc (1 mg/15 g cereal) was added to both oligofructose-supplemented and control cereals. We enrolled 282 infants in the first trial and 349 in the second. In the first trial, mean (+/- SD) days of diarrhea were 10.3 +/- 9.6 in the nonsupplemented cereal group and 9.8 +/- 11.0 in the prebiotic-supplemented cereal group (P = 0.66). In the second trial, mean days of diarrhea were 10.3 +/- 8.9 in the group consuming cereal fortified only with zinc and 9.5 +/- 8.9 in the group consuming cereal containing both zinc and prebiotics (P = 0.35). Postimmunization titers of antibody to Haemophilus influenzae type B were similar in all groups, as were gains in height, visits to clinic, hospitalizations, and use of antibiotics. Cereal supplemented with prebiotics was not associated with any change in diarrhea prevalence, use of health care resources, or response to H. influenzae type B immunization. Infants and young children who continue to breast-feed may not benefit from prebiotic supplementation.