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1
Edward Hines Jr VA Hospital, Hines, Illinois2Stritch School of Medicine, Loyola University Chicago, Maywood, Illinois.
2
Indiana University Health Arnett Hospital, Lafayette.
3
St Joseph's Healthcare Hamilton, McMaster University, Hamilton, Ontario, Canada.
4
Division of Infectious Diseases, University of California at Davis Medical Center, Sacramento.
5
VA Medical Center and Upstate Medical University, Syracuse, New York.
6
Centre de Santé et de Services Sociaux de Trois-Rivières, Trois-Rivières, Québec, Canada.
7
Division of Infectious Disease, University of Nebraska Medical Center, Omaha.
8
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
9
Hospital Universitario Puerta de Hierro, Madrid, Spain.
10
Internal Medicine and Infectious Diseases, University of Colorado Denver, Aurora.
11
Shire, Wayne, Pennsylvania.
1
Edward Hines Jr VA Hospital, Hines, Illinois2Stritch School of Medicine, Loyola University Chicago, Maywood, Illinois.
2
Indiana University Health Arnett Hospital, Lafayette.
3
St Joseph's Healthcare Hamilton, McMaster University, Hamilton, Ontario, Canada.
4
Division of Infectious Diseases, University of California at Davis Medical Center, Sacramento.
5
VA Medical Center and Upstate Medical University, Syracuse, New York.
6
Centre de Santé et de Services Sociaux de Trois-Rivières, Trois-Rivières, Québec, Canada.
7
Division of Infectious Disease, University of Nebraska Medical Center, Omaha.
8
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
9
Hospital Universitario Puerta de Hierro, Madrid, Spain.
10
Internal Medicine and Infectious Diseases, University of Colorado Denver, Aurora.
11
Shire, Wayne, Pennsylvania.
Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted from June 2011 to June 2013 among 173 patients aged 18 years or older who were diagnosed as having CDI (first episode or first recurrence) and had successfully completed treatment with metronidazole, oral vancomycin, or both at 44 study centers in the United States, Canada, and Europe.
Among 168 patients who started treatment, 157 completed treatment. One or more treatment-emergent adverse events were reported in 78% of patients receiving NTCD-M3 and 86% of patients receiving placebo. Diarrhea and abdominal pain were reported in 46% and 17% of patients receiving NTCD-M3 and 60% and 33% of placebo patients, respectively. Serious treatment-emergent adverse events were reported in 7% of patients receiving placebo and 3% of all patients who received NTCD-M3. Headache was reported in 10% of patients receiving NTCD-M3 and 2% of placebo patients. Fecal colonization occurred in 69% of NTCD-M3 patients: 71% with 10(7) spores/d and 63% with 10(4) spores/d. Recurrence of CDI occurred in 13 (30%) of 43 placebo patients and 14 (11%) of 125 NTCD-M3 patients (odds ratio [OR], 0.28; 95% CI, 0.11-0.69; P = .006); the lowest recurrence was in 2 (5%) of 43 patients receiving 10(7) spores/d for 7 days (OR, 0.1; 95% CI, 0.0-0.6; P = .01 vs placebo]). Recurrence occurred in 2 (2%) of 86 patients who were colonized vs 12 (31%) of 39 patients who received NTCD-M3 and were not colonized (OR, 0.01; 95% CI, 0.00-0.05; P < .001).
Among patients with CDI who clinically recovered following treatment with metronidazole or vancomycin, oral administration of spores of NTCD-M3 was well tolerated and appeared to be safe. Nontoxigenic C. difficile strain M3 colonized the gastrointestinal tract and significantly reduced CDI recurrence.
Ray K.
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