The procedure, also known as fecal biotherapy, involves the transfer of saline-diluted fecal matter into a patient’s GI tract through an enema or nasoduodenal catheter. Repopulating the gut with healthy bacteria in this way can dramatically reduce symptoms and put some UC patients into remission, according to small case studies and anecdotal reports. These preliminary findings are raising hopes in the IBD community that this novel treatment could be a possible cure.
McMaster University microbiologist Dr. Michael Surette is the lead investigator for a new CCFC-funded study that will evaluate the effectiveness of fecal transplants in a randomized controlled trial involving 130 UC patients from Ontario at St. Joseph’s Hospital in Hamilton. (The clinical trial is led by Dr. Surette’s co-principal investigators, Dr. Paul Moayyedi and Dr. Christine Lee.)
In an earlier study, the McMaster researchers found that seven of eight UC patients responded to fecal transplants and six patients remained well one year following treatment. “We’re seeing success rates of 80 to 90 per cent. This kind of clinical trial is absolutely essential for a new treatment to become a standard of care,” says Dr. Surette, who holds a Tier 1 Canada Research Chair in Interdisciplinary Microbiome Research and is well known for his research on the complex relationships between bacteria and disease.
A gold-standard clinical trial is needed to prove that fecal transplants are an effective treatment for ulcerative colitis. If the McMaster study shows that a significant number of UC patients are cured or much improved, this would provide the scientific basis for the treatment to be offered widely in major centres across the country. The results are expected within two years.
Another important goal of the CCFC-funded study is to learn more about how and why fecal transplants work, and the critical differences between treatment successes and failures. “There is a huge question about why fecal biotherapy seems to work so well,” says Dr. Surette. “What is the mechanism driving the success rates?”
Researchers believe that an imbalance of harmful bacteria in the gut may be driving the inflammation in ulcerative colitis and that replacing them with helpful bacteria from a healthy donor may reset the patient’s immune system and stop the chronic inflammation.
To investigate this theory and answer these questions, Dr. Surette will be doing sophisticated tests to measure changes in the collective population of helpful and harmful bacteria in the gut in UC patients before and after treatment. (The collective population of helpful and harmful bacteria is known as the microbiome.) “We want to see what bacteria species from the healthy donor get transferred to the patients who are successfully treated and look for differences in the bacteria of patients that fail treatment,” he explains.
This study is unique in that only one to three donors will be used for all the fecal transplants, helping researchers to pinpoint bacteria associated with treatment success or failure.
Learning exactly which microbes from the donor are important will help to make the treatment effective for as many UC patients as possible. This could also lead to more specific targeted therapies in the future with bacteria grown in the lab, for example.
Dr. Surette will look for biomarkers in the intestinal lining of patients as well, which could be used as reliable indicators of the success or failure of treatment. “These biomarkers could help us measure how well the therapy is working and adjust the treatment for each patient to make it more effective. We might be able to better differentiate the disease and determine which patients are the best candidates,” he says.
Despite the “yuck” factor, most patients surveyed say they would choose fecal transplantation as a treatment because it’s more natural than many UC medications.
The McMaster researchers are excited because fecal biotherapy targets the underlying cause of the disease. “Dampening the inflammation with a drug is treating the symptoms and not treating the disease. What’s driving the inflammation is microbial. The immune system is out of kilter. The advantage of changing the microbiome is that it might be a way to reset the immune system. You’re getting at the root cause rather than just the symptoms,” says Dr. Surette.
“This is a very promising therapy, which could potentially be of benefit to many people with ulcerative colitis. This kind of therapy may work in many kinds of inflammatory diseases, including Crohn’s disease.”
McMaster University microbiologist Dr. Michael Surette is the lead investigator for a new CCFC-funded study that will evaluate the effectiveness of fecal transplants in a randomized controlled trial involving 130 UC patients from Ontario at St. Joseph’s Hospital in Hamilton. (The clinical trial is led by Dr. Surette’s co-principal investigators, Dr. Paul Moayyedi and Dr. Christine Lee.)
In an earlier study, the McMaster researchers found that seven of eight UC patients responded to fecal transplants and six patients remained well one year following treatment. “We’re seeing success rates of 80 to 90 per cent. This kind of clinical trial is absolutely essential for a new treatment to become a standard of care,” says Dr. Surette, who holds a Tier 1 Canada Research Chair in Interdisciplinary Microbiome Research and is well known for his research on the complex relationships between bacteria and disease.
A gold-standard clinical trial is needed to prove that fecal transplants are an effective treatment for ulcerative colitis. If the McMaster study shows that a significant number of UC patients are cured or much improved, this would provide the scientific basis for the treatment to be offered widely in major centres across the country. The results are expected within two years.
Another important goal of the CCFC-funded study is to learn more about how and why fecal transplants work, and the critical differences between treatment successes and failures. “There is a huge question about why fecal biotherapy seems to work so well,” says Dr. Surette. “What is the mechanism driving the success rates?”
Researchers believe that an imbalance of harmful bacteria in the gut may be driving the inflammation in ulcerative colitis and that replacing them with helpful bacteria from a healthy donor may reset the patient’s immune system and stop the chronic inflammation.
To investigate this theory and answer these questions, Dr. Surette will be doing sophisticated tests to measure changes in the collective population of helpful and harmful bacteria in the gut in UC patients before and after treatment. (The collective population of helpful and harmful bacteria is known as the microbiome.) “We want to see what bacteria species from the healthy donor get transferred to the patients who are successfully treated and look for differences in the bacteria of patients that fail treatment,” he explains.
This study is unique in that only one to three donors will be used for all the fecal transplants, helping researchers to pinpoint bacteria associated with treatment success or failure.
Learning exactly which microbes from the donor are important will help to make the treatment effective for as many UC patients as possible. This could also lead to more specific targeted therapies in the future with bacteria grown in the lab, for example.
Dr. Surette will look for biomarkers in the intestinal lining of patients as well, which could be used as reliable indicators of the success or failure of treatment. “These biomarkers could help us measure how well the therapy is working and adjust the treatment for each patient to make it more effective. We might be able to better differentiate the disease and determine which patients are the best candidates,” he says.
Despite the “yuck” factor, most patients surveyed say they would choose fecal transplantation as a treatment because it’s more natural than many UC medications.
The McMaster researchers are excited because fecal biotherapy targets the underlying cause of the disease. “Dampening the inflammation with a drug is treating the symptoms and not treating the disease. What’s driving the inflammation is microbial. The immune system is out of kilter. The advantage of changing the microbiome is that it might be a way to reset the immune system. You’re getting at the root cause rather than just the symptoms,” says Dr. Surette.
“This is a very promising therapy, which could potentially be of benefit to many people with ulcerative colitis. This kind of therapy may work in many kinds of inflammatory diseases, including Crohn’s disease.”
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