Jim Kling

October 16, 2013

SAN DIEGO — Fecal microbiota transplantation is safe and effective for treating Clostridium difficile infection in immunocompromised patients, according to a new study.

There has been concern about using fecal transplants in immunocompromised patients because there are no guidelines or data to support the procedure in these patients. "A lot of people who could benefit from having their C difficile treated do not undergo this treatment," said Chioma Ihunnah, MD, resident internal medicine physician at Brown University in Providence, Rhode Island.

Dr. Ihunnah presented the study results here at the American College of Gastroenterology 2013 Annual Scientific Meeting and Postgraduate Course.

Dr. Ihunnah and her team conducted a retrospective study of immunocompromised patients at 16 centers to evaluate the safety and efficacy of fecal transplantation. They identified 83 patients who had the procedure for recurrent (12%), refractory (54%), or severe (34%) C difficile infection.

 
This is an important study because C difficile in immunocompromised patients tends to be quite severe and can be life-threatening.
 

They analyzed data from the 61 adults and 5 children who completed at least 12 weeks of post-transplant follow-up. Mean follow-up was 12 months (range, 3 to 51 months).

The majority — 78% — were outpatients at the time of the procedure. Two patients were immunocompromised because of HIV/AIDS, 14 because of solid organ transplant, 6 because of oncologic conditions, 32 because of immunosuppressive therapy for inflammatory bowel disease, and 12 because of other medical conditions or medications.

The cure rate for C difficile infection after a single fecal transplant was 79% (52 of 66 patients). That rate rose to 89% after 7 of the 9 patients who underwent a second transplant were cured.

Within 12 weeks of the procedure, 10 patients (15%) experienced a serious adverse event — 8 required hospitalization and 2 died. One death was the result of aspiration during sedation for the procedure and the other was reportedly unrelated to the transplant.

No infections were traced to the procedure. One patient developed an unrelated infection, and 2 patients developed diarrhea with no identified causal organism, which the researchers believe was not linked to the transplant.

Three patients with inflammatory bowel disease experienced flare-ups after fecal transplantation. Two patients with ulcerative colitis underwent colectomy related to that condition more than 100 days after the transplantation. One patient experienced a mucosal tear during transplantation, and 4 patients reported mild abdominal discomfort.

This moderately sized, international, multicenter study is a starting point for "showing the medical community that fecal transplant can be done in immunocompromised patients and without a large number of adverse effects," said Dr. Ihunnah. The more people who expand their perspective on fecal transplantation, the more data we will have, she noted.

Serious Adverse Events

"This is an important study because C difficile in immunocompromised patients tends to be quite severe and can be life-threatening," said session moderator Jonathan Leighton, MD, from the Mayo Clinic Arizona in Scottsdale.

"We need effective therapies. I think there was reasonable concern that fecal transplants might be a higher-risk procedure in these patients. That doesn't appear to be the case, at least from an infection standpoint," he told Medscape Medical News.

The study did raise one concern — the 15% incidence of serious adverse events. "We need to understand that a little bit more before saying that this is completely safe in that subset of patients," he added.

It isn't clear whether the adverse events were related to the fecal transplant itself, or to the procedure that was used to deliver the transplant. "That clarification is going to be very important," said Dr. Leighton.

Dr. Ihunnah and Dr. Leighton have disclosed no relevant financial relationships. Members of the research team report being on the speaker's bureau or receiving research support from CIPAC, Optimer Pharmaceuticals, and Cubist.

American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting and Postgraduate Course: Abstract 10. Presented October 14, 2013.

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