MedicalResearch.com Interview with:
Monika Fischer, MD, MSCR
Assistant Professor of Clinical Medicine
Division of Gastroenterology and Hepatology
Indianapolis, IN 46202
Medical Research: What is the background for this study? What are the main findings?
Dr. Fischer: Cumulative evidence based upon case series and randomized trials suggest high success rate with 10-20 % failing a single FMT (fecal microbiota transplant). Predictors of failures are not known. In a collaborative study between Indiana and Brown Universities we aimed to identify clinical predictors of FMT failure.
Results were the following:
- N= 345 patients
- Brown: N=166
- IU: N=179
- Average age: 62 years
- Females: 72%
- IBD: 18%
- Immunosuppression: 24%
- Indication for FMT
- Recurrent CDI: 74%
- Refractory CDI: 26%
- Severe/complicated CDI: 13%
- Inpatient FMT: 17%
- Patient directed donor: 40%
Overall failure rate was 23.7%. Broken down by fecal microbiota transplant indication, while only 18% of patients failed and needed further therapy in the non-severe category, 1 in 2 (50%) severe C. difficile infection (CDI) patients failed a single fecal microbiota transplant and needed further therapy for cure.
Medical Research: What should clinicians and patients take away from your report?
Dr. Fischer: Overall failure rate was 23.7%. Broken down by fecal microbiota transplant indication, while only 18% of patients failed and needed further therapy in the non-severe category, 1 in 2 (50%) severe CDI patients failed a single FMT and needed further therapy for cure.
We found linear correlation between white blood cell count (WBC), albumin concentration and number of previous C. difficile infection related hospitalization. Patients with higher WBC, lower albumin, and greater number of CDI-related hospitalizations are more likely to fail at 3 months.
Based on the multivariable analysis, we found 3 independent predictors of failing a single FMT at 3 months: inpatient status at the time of fecal microbiota transplant , immunosuppression and previous C. difficile infection related hospitalizations. Inpatients were 7 times more likely to fail a single fecal microbiota transplant while immunosuppressed 3.5 more likely to fail fecal microbiota transplant at 3 month. In addition, patients with greater number of CDI-related hospitalization prior to FMT are more likely to have a failure outcome. With every additional hospitalization, the odds of failure increases by 45%.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Fischer: Using the coefficients of final predictors we created a risk scores and a risk stratification model (scores ranging from 0-12), assigned 5 points to inpatients status, 3 points to immunosupressed state and 1 point for each C. difficile infection related hospitalization. We then computed the risk score for each patient by adding the points for each risk factor in the model and created low/moderate/ high risk categories of FMT failure. After applying this model to our data set we found that patients in the low risk category have a 13% chance of failing, patients with 1-3 scores fail in 17% of cases and patient with 4 or higher scores have a chance of failing in at least 44% of the time.
We hope that physicians will find the proposed risk stratification model helpful when planning and discussing fecal microbiota transplant with their patients and in terms of being prepared for a repeat fecal microbiota transplant among high risk patients.
ACG 2015 abstract:
Monika Fischer MD. (2015). Three Factors Identify Risk of Fecal Transplant Failure for C. Diff Infections