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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
The data regarding the safety and efficacy of fecal microbiota transplantation for patients with C difficile infections and inflammatory bowel disease has been limited.
A new analysis shows fecal microbiota transplantation (FMT) is effective a curing patients with clostridium difficile infections (CDI) and underlying inflammatory bowel disease (IBD).
A team, led by Raseen Tariq, MBBS, Division of Gastroenterology and Hepatology Mayo Clinic libraries, Mayo Clinic, conducted a systematic review and meta-analysis to identify the efficacy and safety of FMT for patients with CDI and IBD, particularly what the impact is on IBD outcomes.
FMT has been effective in recent years as a treatment for recurrent CDI. However, there limited and conflicting data for using FMT in patients with C difficile infections and underlying IBD.
The investigators examined various databases to identify studies focused on pooled rates of CDI resolution after single and multiple fecal microbiota transplantations in patients with IBD. Some additional analysis included rates of IBD-associated outcomes, such as flare, surgery, and symptom improvement following FMT.
The team used a random-effects model to calculate pooled rates.
Overall, the studies included 457 adult patients, 363 of which had CDI resolution following the first transplantation. The pooled cure rate was 78% (95% CI, 73-83%; I2 = 39%).
The overall pooled cure rate with single and multiple transplantations was 26.8% (95% CI, 22.5-31.6%; I2 = 9%).
For IBD flares, the pooled rate after FMT was 26.8% (95% CI, 22.5-31.6%; I2 = 9%). For colectomy, the pooled rate following FMT was 7.3% (95% CI, 4.7-10.5%; I2 = 56%).
The investigators also analyzed 141 pediatric patients, 106 of which had CDI resolution after the first FMT. The pooled cure rate of this patient subgroup was 78% (95% CI, 58-93%; I2 = 59%) with an overall pooled cure rate with single and multiple FMT of 77% (95% CI, 50%-96%; I2 = 63%).
The pooled cure rate of an IBD flare after FMT was 10.8% (95% CI, 5.7%-18.5% I2 = 43%), while the pooled cure rate of colectomy after FMT was 10.3% (95% CI, 2.1%-30.2% I2 = 23%).
“FMT appears to be a highly effective therapy for preventing recurrent CDI in patients with IBD,” the authors wrote. “Patients who fail a single FMT may benefit from multiple FMTs.”
While FMT is not approved by the US Food and Drug Administration (FDA) and likely won’t be, many companies are preparing to build on the underlying science and create a new wave of live microbiota treatments.
There are at least 3 of these treatments in later phase trials that could be approved within the next year.
RBX2660 is a standardized, stabilized, investigational microbiota-based live therapeutic.
CP101 is an investigational orally administered microbiome therapeutic designed to restore microbiome diversity and enable early intervention in the management of recurrent CDI.
SER-109, an investigational, biologically derived microbiome treatment of purified Firmicute spores.
The study, “Outcomes of Fecal Microbiota Transplantation for C. difficile Infection in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis,” was published online in the Journal of Clinical Gastroenterology.