title: Orally administered bovine colostral anti-cholera toxin antibodies: results of two clinical trials.
abstract: OBJECTIVE
  Previous reports have suggested that binding of luminal toxin by orally administered antitoxin antibodies might be a feasible treatment for cholera. We therefore conducted two randomized, controlled clinical trials to test the therapeutic efficacy of orally administered anti-cholera toxin bovine colostral immunoglobulins in patients with cholera diarrhea.
  
  
  METHODS
  In Trial I, 45 patients with cholera were randomly assigned to receive two doses (2 g in 100 ml of water each) of anti-cholera toxin bovine colostral immunoglobulins, non-immune bovine colostral immunoglobulins, or 100 ml of water alone. In Trial II, 20 patients were randomly assigned to receive either 2 g of anti-cholera toxin bovine colostral immunoglobulins or non-immune bovine colostral immunoglobulins or water every two hours for a total of eight doses. The mean stool volumes in each of two sequential eight-hour periods following initiation of therapy were not significantly different among study groups in either trial.
  
  
  RESULTS
  Measurement of immunoglobulin in stools showed that bovine IgG was detected in 19 of 25 patients given bovine colostral immunoglobulins in both trials. Cholera toxin neutralizing activity, as assessed with the rabbit ileal loop assay, was found in the stools of three of seven patients given anti-cholera toxin bovine colostral immunoglobulins in Trail I, and in all six patients given anti-cholera toxin bovine colostral immunoglobulins in Trail II.
  
  
  CONCLUSIONS
  We conclude that oral anti-cholera toxin bovine colostral immunoglobulins are not effective in the treatment of patients with active cholera diarrhea. The prophylactic benefit of oral antitoxin antibody remains to be determined.
authors.affiliation: Department of Pediatrics, Ohio State University 43205.
authors.forename: R E
authors.initials: RE
authors.lastname: McClead
authors.forename: T
authors.initials: T
authors.lastname: Butler
authors.forename: G H
authors.initials: GH
authors.lastname: Rabbani
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000818:Animals; D002417:Cattle; D002771:Cholera / Q000276:immunology / Q000628:therapy*; D002772:Cholera Toxin / Q000276:immunology*; D002986:Clinical Trials as Topic; D003126:Colostrum / Q000276:immunology*; D005243:Feces / Q000032:analysis; D006801:Humans; D007116:Immunization, Passive; D007070:Immunoglobulin A / Q000032:analysis; D007074:Immunoglobulin G / Q000032:analysis; D008297:Male; D009500:Neutralization Tests; D011897:Random Allocation
chemical_list: D007070:Immunoglobulin A; D007074:Immunoglobulin G; D002772:Cholera Toxin