Safety of fecal transplant to treat C. difficile examined in study 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." Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3. Fecal Microbiota Transplant for Treatment of Clostridium difficile Infection in Immunocompromised Patients. Kelly CR1, Ihunnah C1, Fischer M2, Khoruts A3, Surawicz C4, Afzali A4, Aroniadis O5, Barto A6, Borody T7, Giovanelli A8, Gordon S9, Gluck M10, Hohmann EL11, Kao D12, Kao JY13, McQuillen DP6, Mellow M14, Rank KM3, Rao K13, Ray A15, Schwartz MA10, Singh N16, Stollman N8, Suskind DL16, Vindigni SM4, Youngster I11, Brandt L5. Author information Abstract OBJECTIVES: Patients who are immunocompromised (IC) are at increased risk of Clostridium difficile infection (CDI), which has increased to epidemic proportions over the past decade. Fecal microbiota transplantation (FMT) appears effective for the treatment of CDI, although there is concern that IC patients may be at increased risk of having adverse events (AEs) related to FMT. This study describes the multicenter experience of FMT in IC patients. METHODS: A multicenter retrospective series was performed on the use of FMT in IC patients with CDI that was recurrent, refractory, or severe. We aimed to describe rates of CDI cure after FMT as well as AEs experienced by IC patients after FMT. A 32-item questionnaire soliciting demographic and pre- and post-FMT data was completed for 99 patients at 16 centers, of whom 80 were eligible for inclusion. Outcomes included (i) rates of CDI cure after FMT, (ii) serious adverse events (SAEs) such as death or hospitalization within 12 weeks of FMT, (iii) infection within 12 weeks of FMT, and (iv) AEs (related and unrelated) to FMT. RESULTS: Cases included adult (75) and pediatric (5) patients treated with FMT for recurrent (55%), refractory (11%), and severe and/or overlap of recurrent/refractory and severe CDI (34%). In all, 79% were outpatients at the time of FMT. The mean follow-up period between FMT and data collection was 11 months (range 3-46 months). Reasons for IC included: HIV/AIDS (3), solid organ transplant (19), oncologic condition (7), immunosuppressive therapy for inflammatory bowel disease (IBD; 36), and other medical conditions/medications (15). The CDI cure rate after a single FMT was 78%, with 62 patients suffering no recurrence at least 12 weeks post FMT. Twelve patients underwent repeat FMT, of whom eight had no further CDI. Thus, the overall cure rate was 89%. Twelve (15%) had any SAE within 12 weeks post FMT, of which 10 were hospitalizations. Two deaths occurred within 12 weeks of FMT, one of which was the result of aspiration during sedation for FMT administered via colonoscopy; the other was unrelated to FMT. None suffered infections definitely related to FMT, but two patients developed unrelated infections and five had self-limited diarrheal illness in which no causal organism was identified. One patient had a superficial mucosal tear caused by the colonoscopy performed for the FMT, and three patients reported mild, self-limited abdominal discomfort post FMT. Five (14% of IBD patients) experienced disease flare post FMT. Three ulcerative colitis (UC) patients underwent colectomy related to course of UC >100 days after FMT. CONCLUSIONS: This series demonstrates the effective use of FMT for CDI in IC patients with few SAEs or related AEs. Importantly, there were no related infectious complications in these high-risk patients.