The gut microbiome is a bustling ecosystem of microorganisms. Preliminary research indicates that microbiota therapeutics, such as fecal transplants, may eventually aid in the management of ulcerative colitis and Crohn’s disease. Existing treatments for inflammatory bowel disease (IBD) are not effective in maintaining remission for all patients.
People suffering from inflammatory bowel disease (IBD) who do not find relief through targeted drug therapies might have an alternative path to remission through microbiota therapeutics, such as fecal transplants, according to a new study. This study provides hope that incorporating these innovative treatments into existing regimens could help manage IBD symptoms more effectively.
The research team examined data from 15 clinical trials that explored the effectiveness of fecal microbiota transplants (FMT). FMT involves introducing stool containing healthy microorganisms into the digestive system of patients. This method was tested on individuals diagnosed with ulcerative colitis, Crohn’s disease, and Clostridioides difficile (C. difficile) infections. The analysis indicated that FMT could potentially restore a healthy balance of gut bacteria, thereby alleviating symptoms for those who have not responded to conventional therapies.
“Microbiota therapeutics use the microbes that are found in the gut of healthy people as a drug to treat a disease or condition,” study coauthor Ari Grinspan, MD, an associate professor and director of the FMT program at the Icahn School of Medicine at Mount Sinai in New York City, shared. “They are essentially the ultimate probiotic.”
Although fecal microbiota transplantation (FMT) is currently an experimental treatment for ulcerative colitis and Crohn’s disease, preliminary results from early-stage trials indicate promising potential, according to Dr. Grinspan. This optimism stems from the observation that individuals with IBD often possess an imbalanced gut microbiome—comprising bacteria, fungi, parasites, and viruses—lacking the essential mix of healthy organisms.
Microbiota therapeutics such as FMT are thought to help with IBD symptoms by increasing the population of healthy organisms found in the digestive tract, Grinspan explained. “They drastically increase the richness and diversity of the microbiota in the human colon and bring back the normal function of the gut microbiome,” Grinspan added.
FMT Medications that Have been Approved by the FDA
To date, the U.S. Food and Drug Administration (FDA) has approved two fecal microbiota transplant (FMT) medications, Rebyota and Vowst, specifically for the prevention of recurrent C. difficile infections. According to Dr. Grinspan, these infections are characterized by dysbiosis, which is a lack of normal diversity in the gut microbiome.
“Inflammatory bowel disease is also characterized by dysbiosis in the gut microbiome,” Grinspan said. “So, the theory is that if we can restore the normal healthy diversity and richness of the gut microbiome in patients with IBD, then maybe we can help treat the disease.”
In five early-stage trials involving over 300 individuals with mild-to-moderate ulcerative colitis, fecal microbiota transplantation (FMT) led to symptom remission in approximately 30 percent of participants. In contrast, only about 10 percent of those in the placebo group experienced remission, according to the new study.
“Several FMT trials have demonstrated benefits for patients with mild-to-moderate ulcerative colitis, with some patients achieving steroid-free remission,” Iliyan Iliev, PhD, an associate professor of microbiology and co-director of the microbiome core laboratory at Weill Cornell Medicine in New York City, said. Many patients suffering from ulcerative colitis can’t achieve remission without constantly taking steroids to manage their symptoms, Dr. Iliev, who wasn’t part of the new study, said.
According to the new study, earlier trials of fecal microbiota transplantation (FMT) indicate that the treatment may be most effective when patients undergo a course of antibiotics prior to the procedure.
IBD Early Trials
Current testing indicates that initial fecal microbiota transplantation (FMT) interventions may be most effective when administered via endoscopy—a nonsurgical procedure where a tube is inserted through the throat to reach the digestive tract. For patients with inflammatory bowel disease (IBD), maintaining remission might require additional FMT treatments. In these cases, FMT capsules could be a viable option, the study suggests.
While less is known about the effectiveness of FMT in Crohn’s disease patients, the study reviewed two early-stage trials involving 44 participants. In these trials, two-thirds of the patients in one study and 87 percent of the participants in the other achieved remission following FMT treatment.
However, one limitation of the new study is the lack of data on the optimal ways to combine FMT with targeted drugs that are currently the standard of care for IBD. Patients with severe IBD are often treated with biologic therapies such as infliximab (Remicade), adalimumab (Humira), or ustekinumab (Stelara). The integration of FMT with these targeted treatments remains an area requiring further research.
“The existing treatments cannot keep all patients in remission, therefore, microbiota therapeutics are needed,” Jun Sun, PhD, a professor and IBD researcher at the University of Illinois in Chicago, said. He also who wasn’t part of the new study made. “It is still unknown if the combination of biologics and microbiota treatment is best for patients with IBD,” Dr. Sun said.
Trials Made for C. Difficile Infections
A review of 26 studies on fecal microbiota transplantation (FMT) for C. difficile infections found that oral capsules were just as effective as the more invasive colonoscopy method for administering FMT to prevent recurrent infections, according to the new study.
The study authors highlight several challenges associated with FMT. One major obstacle is the need for stool from healthy donors to formulate treatments, which can limit availability and consistency. Additionally, there is still uncertainty regarding the precise FMT dosage required to help patients with inflammatory bowel disease (IBD) achieve and maintain remission. This lack of clarity poses a significant hurdle in standardizing FMT as a reliable treatment option for IBD patients.
The researchers emphasize the importance of further studies to determine the optimal dosage and administration methods for FMT, as well as to explore ways to effectively combine FMT with current targeted drug therapies. This ongoing research is crucial for enhancing the efficacy and accessibility of FMT in treating IBD and other related conditions.
“FMT is inherently crude, complex, and challenging to standardize,” Iliev said.
However, Dr. Grinspan suggests that ongoing research into fecal microbiota transplantation (FMT) for ulcerative colitis and Crohn’s disease holds promise, given the positive outcomes seen with C. difficile infections. Dr. Grinspan believes these efforts are crucial because current treatments for inflammatory bowel disease (IBD) are often inadequate, and there has been minimal advancement in treatment options over the past decade. Therefore, exploring FMT as a potential therapy could significantly improve the quality of life for IBD patients.
FMT Has ‘Great Potential’ When Treating IBD
“The use of microbiota therapeutics holds great potential for achieving remission in patients with IBD,” Grinspan said.
Currently, patients with ulcerative colitis and Crohn’s disease can only receive fecal microbiota transplantation (FMT) interventions through clinical trials, Dr. Grinspan notes. Accessing these studies can be challenging, especially for those living outside major metropolitan areas where most medical research is conducted. Moreover, even if patients manage to join a trial, there is still a significant chance they might receive a placebo instead of the actual FMT treatment.
Despite the promising results from trials conducted so far, Dr. Grinspan cautions that outcomes are not guaranteed. Further research is necessary to fully understand and validate the efficacy of FMT for these conditions.
“FMT for IBD is not ready for prime time,” Grinspan said. “I am optimistic that we will find the right population that will benefit from microbial therapeutics — but we have a lot more to learn.”
Recommended For You
