Duodenal Infusion of Donor Feces for

Recurrent Clostridium difficile

The New England Journal of MedicineJanuary 31, 2013

Debi Armbruster

Hypothesis

• The effect of duodenal infusion of donor feces in patients with recurrent C. difficile infection will be more effective for treatment than antibiotic therapy, Vancomycin, both with and without bowel lavage.

Questions:

• Experience is limited

Study Design

• Open label, randomized, controlled trial

• 3 treatment regimens• Infusion of donor feces preceded by an abbreviated regiment of

Vancomycin and bowel lavage

• Standard Vancomycin regimen

• Standard Vancomycin with bowel lavage

Infusion of Donor Feces

• Donors• <60 years of age

• Screened using a questionnaire addressing

• Risk factors for transmissible diseases

• Screened for parasites

• Blood screening

• Donor pool created and screening was repeated every 4 months

Study Design

• Independent Variable: Duodenal infusion of donor feces

• Dependent Variable: Recurrent C. difficile infection

Outcomes

• Cure• Primary end point

• Secondary end point

• Relapse

• Analysis of Fecal Microbiota

Exposures and Outcomes

• Primary end point: Cure without relapse within 10 weeks after initiation of therapy

• Secondary end point: Cure without relapse after 5 weeks

• Bacterial diversity: Simpson’s Reciprocal Index of diversity, scale ranging from 1-250

***higher the score higher the diversity

Study population

• At least 18 years of age

• Life expectancy of at least 3 months

• A relapse of C. difficile infection after at least one course of adequate antibiotic therapy

• > 10 days of Vancomycin >125 mg 4 times a day

• >10 days of Metronidazole 500 mg 3 times per day

• Exclusions:

• Prolonged compromised immunity due to chemotherapy, HIV, prolonged use of prednisolone

• Pregnancy

• Use of antibiotics other than for treatment of C diff

• Admission to an ICU

• Need for vasopressor medication

Results

• Donor feces• Cured 15 of 16 patients (94%)

• Vancomycin• Resolution 4 of 13 patients (31%)

• Vancomycin with bowel lavage• Resolution 3 of 13 patients (23%)

Critique

• Alternative interpretations• “first line therapy”

• Additional Controls• Amount of feces

• Potential routes of infusion

• Cofounders• Massachusettes Medical Society

• Netherlands Organization for Health Research and Development

Final Remarks

• Nutritional Recommendations for C. difficile:• The use of probiotics found in fermented foods or over-the-counter

probiotic supplement.

• Soft foods diet

• Avoiding nuts, seeds, foods high in fiber, and gas-producing

• Easy to chew

• Protocol for standard of practice

References

• M.D., E. N. Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. The New England Journal of Medicine, 368, 407-415.

Questions?