Summary: Based on experimental evidence in animals showing that the oral administration of Saccharomyces boulardii is effective in reducing morbidity and mortality due to Clostridium difficile-induced pseudomembranous colitis, we conducted an open trial to examine the effects of the living yeast, given as primary therapy, in a selected group of infants and children with persistent intestinal symptoms related to toxinogenic C. difficile overgrowth. Over a period of 10 consecutive months, we studied 19 eligible patients (median age 8 months) who presented with enteral symptoms lasting for > 15 days and who had solely C. difficile in stools with positive cytotoxin B assay. Serotyping of the strains and determination in vitro of production of toxins A and B were performed subsequently. The patients presented with persistent or protracted diarrhea, malabsorption, and failure to grow (n = 8), or with repeated attacks of colics, emesis, and hypermeteorism without diarrhea (n = 4), or with both entities (n = 7). Patients with chronic protracted diarrhea (n = 3) had-depressed jejunal disaecharidase activities and ultrastructural changes of enterocytes, including sparce and shortened microvilli. None had evidence of colitis. All the strains of C. difficile tested (n = 17) belonged to pathogenic serotypes (A1, A8, C, F, G, H, and K) and produced in vitro high levels of toxins A (n = 16) and B (n = 17). S. boulardii was given orally in a lyophilized form over 15 days (250 mg two to four times per day according to age). Within 1 week of treatment, enteral symptoms and physical findings resolved in 18 patients (95%) with marked decreases (p < 0.001) in the number of stools, frequency of colic episodes, and total duration of colics per day. Clearing of toxin B was observed within 15 days of therapy in 16 cases (85%), whereas eradication of C. difficile from stools was complete after 1 month in 14 (73%). Also, the ultrastructural changes observed in patients with chronic protracted diarrhea (n = 3) had disappeared after 1 month. A clinical and bacteriological relapse occurred in two patients (11%), which resolved rapidly with a second 15-day course of S. boulardii. These findings suggest that some toxinogenic strains of C. difficile may cause chronic enteropathies without colitis that may be improved by oral administration of S. boulardii.
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