A study was undertaken to investigate whether toxin produced in the gut lumen contributes significantly to clinical illness and whether binding such toxin by GM1 ganglioside adsorbed onto charcoal could alter the clinical course of disease. 46 patients with severe cholera receiving standard intravenous therapy were randomly assigned to one of three groups: GM1 ganglioside-charcoal (16), charcoal alone (16), or water (14). The results demonstrated that patients were given sufficient GM1 ganglioside-charcoal to bind all luminal toxin produced by Vibrio choleræ in their intestines. Patients treated with GM1 ganglioside tended to have a greater reduction in purging than patients treated with either charcoal alone or water. This difference was statistically significant soon after beginning medication (8-15 h) and the reduction in fluid-loss was especially pronounced in patients with very severe initial purging who had been ill only for a short time before admission. These results suggest that toxin produced in the gut lumen increases fluid-loss early in cholera, but that later in the course of disease, toxin which is inaccessible to luminal binding agents is the major stimulus of purging.
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