Fecal microbiota transplantation successfully treated severe and/or complicated Clostridium difficile infection in a retrospective, multicenter, long-term follow-up study of 17 patients in whom conventional therapy had failed.
The 14 inpatients and 3 outpatients were treated for either severe or complicated C. difficile infection (4 patients) or for both severe and complicated infection (13 patients). They were followed for a mean of 11 months (ranging from 1 to 42 months) after fecal microbiota transplantation.
Dr. Olga C. Aroniadis
In 16 patients with diarrhea before transplantation, the diarrhea resolved in 12 patients over an average of 6 days after fecal microbiota transplantation and improved in 4 patients. In 11 patients with abdominal pain before transplantation, the pain resolved in 8 patients over a mean of 10 days and improved in 3 patients, Dr. Olga C. Aroniadis and her associates reported.
Fifteen of 17 patients had no recurrence of C. difficile infection within 90 days of transplantation, for a primary cure rate of 88%. One of the two patients with a recurrence within 90 days was treated successfully with a second fecal microbiota transplantation, for a secondary cure rate of 94%, said Dr. Aroniadis of Montefiore Medical Center, New York.
Patients were considered cured if symptoms of C. difficile infection resolved or improved enough for the patient to be discharged from the hospital, she said in an interview. "In some patients, bowel habits do not return to baseline after successful treatment of C. difficile infection and patients have intermittent diarrhea and soft stools, but these patients no longer have C. difficile. This is what we experienced with some of our patients who we considered to be cured," she said.
One patient developed a late recurrence (more than 90 days after initial transplantation) in association with taking antibiotics to treat diverticulitis. The recurrent C. difficile infection was treated successfully with repeat fecal microbiota transplantation.
Dr. Aroniadis reported the results at the James W. Freston conference sponsored by the American Gastroenterological Association.
The cure rates are similar to results in previous studies of patients who underwent fecal microbiota transplantation for recurrent C. difficile infection who did not have severe or complicated disease, she said.
The 17 patients in the current study had failed conventional medical therapy with antibiotics such as metronidazole and oral vancomycin prior to fecal microbiota transplantation. Many were hospitalized in the ICU and on vasopressor support, she said.
"It’s truly a rewarding experience to watch these severely ill patients improve after fecal transplantation," Dr. Aroniadis said. "Fecal transplantation even obviated the need for colectomy in one of our patients."
Fecal microbiota transplantation for C. difficile infection can be performed by infusing a donated fecal suspension into the gastrointestinal tract via colonoscopy, upper endoscopy, flexible sigmoidoscopy, or enema. Physicians should "use their clinical judgment when determining the appropriate route of administration in patients with severe or complicated C. difficile infection who may be at increased risk for complications from colonoscopy due to colonic dilation and poor bowel wall integrity," Dr. Aroniadis said.
In the study, C. difficile infection was considered severe if the patient had abdominal tenderness, an albumin level less than 3 g/dL, or a WBC count greater than 15,000 cells/mcL, in accordance with published guidelines, she said. Infection was considered complicated if it necessitated ICU care or if the patient had hypotension with or without the use of vasopressors, a change in mental status, a WBC count greater than 35,000 cells/mcL or less than 2,000 cells/mcL, serum lactate levels of 2.2 mmol/L or greater, end-organ failure, a fever of at least 38.5 °C, or ileus or significant abdominal tenderness.
Patients had a mean age of 66 years (ranging from 38 to 89 years), and 13 of them were women.
Dr. Aroniadis reported having no financial disclosures.
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