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PUBLIC RELEASE DATE:
9-Jul-2014

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Contact: Elena Falcone-Relvas
efalconerelvas@lifespan.org
401-793-7484
Lifespan

Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile

First study to look systematically at safety outcomes after fecal transplant in immunocompromised patients

PROVIDENCE, R.I. - Researchers have found that fecal transplantation is effective and safe for treating C. difficile in immunocompromised patients. This is the result of a study led by Colleen Kelly, M.D., a gastroenterologist in the Center for Women's Gastrointestinal Medicine at The Women's Medicine Collaborative. The study and its findings have been published online in advance of print in the American Journal of Gastroenterology.

Clostridium difficile, or C. diff, has increased to epidemic proportions over the past decade. It is an infection that is often difficult to treat and leaves sufferers with frequent diarrhea, abdominal pain, nausea, and fever and can lead to dehydration, loss of appetite and weight loss. Patients who are immunocompromised, or considered high-risk, are more susceptible, and historically, there has been concern that these patients may be at increased risk of infections related to fecal transplant. However, this study found fecal transplant to be effective for the treatment of C. diff infection among immunocompromised patients.

"To date, no study has consistently investigated the safety and efficacy of fecal transplant in immunocompromised patients," Kelly said. "These patients have previously been excluded from clinical trials of fecal transplant because of the fear that they are at high risk of infection related to the procedure. As a result, doctors might be cautious about treating patients with compromised immune systems using fecal transplant."

Increased lengths of stay in hospitals and extended-care facilities, in addition to broad-spectrum antibiotics, increase C. diff infection risk among immunocompromised patients. The infection is responsible for 15 to 25 percent of hospital acquired antibiotic-associated diarrhea and has increased rapidly over the past 10 years to an incidence of 10.4 cases per 1,000 patient admissions. Recurrence is common and occurs in up to 20 percent of patients after initial treatment for C. diff infection.

Kelly and her colleagues have treated a number of immunocompromised patients with fecal transplant, and sought to use this collective experience to describe C. diff infection cure rates among immunocompromised individuals, as well as adverse events, such as death or hospitalization, experienced by immunocompromised patients after fecal transplant. Researchers reviewed the records of 75 adult and five pediatric patients with fecal transplant for C. diff infection. Reasons for being immunocompromised included: HIV/AIDS, solid organ transplant, an oncologic condition, immunosuppressive therapy for inflammatory bowel disease, and other medical conditions/medications, such as cirrhosis and end stage kidney disease.

Analysis found an overall cure rate of 89 percent. While not directly related to fecal transplant, 12 patients had serious adverse effects (such as hospitalization) within 12 weeks of the procedure. Among these were two deaths - one resulted from aspiration during sedation for the colonoscopy used to administer fecal transplant; the other was unrelated to fecal transplant. Some patients with inflammatory bowel disease experienced disease flares after transplant, but no patient suffered infections related to fecal transplant.

"Our study demonstrated the effective use of fecal transplant for C. diff infection in immunocompromised patients with few undesired harmful effects, and, importantly, there were no related infectious complications in these high-risk patients," Kelly said. "The key message here is that physicians do not need to be afraid to use fecal transplant in patients who are immunocompromised. Our findings show fecal transplant is both safe and effective in immunocompromised patients."

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Kelly's primary affiliation is The Women's Medicine Collaborative. She is also an assistant professor of medicine at The Warren Alpert Medical School of Brown University and a faculty member in the fellowship pathway in women's gastrointestinal diseases at Alpert Medical School. Other researchers in the study include Chioma Inunnah, M.D., also of the Women's Medicine Collaborative and the Division of Gastroenterology at the Alpert Medical School; Monika Fischer, M.D., of the Indiana University School of Medicine; Alexander Khoruts, M.D, and Kevin Rank, M.D., of the University of Minnesota Medical School; Christina Surawicz, M.D., Anita Afzali, M.D., and Stephen Vindigni, M.D., of the University of Washington School of Medicine; Olga Aroniadis, M.D., and Lawrence Brandt, M.D., of the Montefiore Medical Center, Albert Einstein College of Medicine; Amy Barto, M.D., and Daniel McQuillen, M.D., of the Lahey Clinic Hospital and Medical Center and Tufts University School of Medicine; Thomas Borody, M.D., of the Centre for Digestive Diseases; Andrea Giovanelli, B.S., and Neil Stollman, M.C., of Northern California Gastroenterology Consultants; Shelley Gordon, M.D., of the California Pacific Medical Center; Michael Gluck, M.D., and Margot Schwartz, M.D., of the Virginia Mason Medical Center; Elizabeth Hohmann, M.D., and IIan Youngster, M.D., of Massachusetts General Hospital, Boston Children's Hospital and Harvard Medical School; Dina Kao, M.D., of the University of Alberta; John Kao, M.D., and Krishna Rao, M.D., of the University of Michigan; Mark Mellow, M.D., of the Integris Baptist Medical Center; Arnab Ray, M.D., of the Ochsner Clinic Foundation; and Namita Singh, M.C., and David Suskind, M.D., of the Seattle Children's Hospital.

About the Women's Medicine Collaborative

The Women's Medicine Collaborative is Rhode Island's largest multi-specialty center dedicated to caring for women at all stages of life. The Collaborative offers coordinated, patient-centered and personalized care all under one roof, including obstetric medicine, women's primary care, women's behavioral medicine, specialty services for non-pregnant and pregnant women, and the Center for Women's Gastrointestinal Medicine. All care is provided by women, and physicians and nurse practitioners are all board certified, with many serving as faculty at The Warren Alpert Medical School of Brown University. The Women's Medicine Collaborative is a Lifespan partner. Follow us on Facebook and on Twitter (@WomensMedicine).



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