Australian scientists said the findings could pave the way for such transplants to be used on a more widespread basis. Transferring fecal matter from healthy donors into these patients alters the composition of their gut bacteria, circumventing one of the drivers of ulcerative colitis, experts said.
"We were not completely surprised by the study findings, as . . . smaller studies along with unpublished experience suggested repeated fecal microbiota transplantation may be an effective treatment for ulcerative colitis," said study author Dr. Sudarshan Paramsothy, a gastroenterologist at University of New South Wales. "This study shows that [stool transplant] is a very promising therapeutic option for ulcerative colitis patients."
Up to 700,000 Americans suffer from ulcerative colitis, a chronic disease believed to stem from an abnormal immune system response, according to the Crohn's and Colitis Foundation of America. The condition causes the lining of the colon to become inflamed and develop tiny, open ulcers. Symptoms include bloody stools, abdominal pain and persistent diarrhea.
Currently, stool transplants -- which experts acknowledge come with a "yuck" factor -- are standard treatment only for virulent Clostridium difficile gastrointestinal infections. These infections can be life-threatening.
Across three Australian study sites, Paramsothy and his team analyzed 81 ulcerative colitis patients whose disease had proved resistant to standard treatments such as steroids or anti-inflammatory medications.
Participants were randomized into two groups, with 41 receiving repeated fecal transplants over eight weeks and the rest receiving a placebo.
The fecal matter used for transplantation had been derived from at least three donors per participant, to minimize the chances that a single donor's gut bacteria could skew results.
Donor stool was homogenized and filtered, then frozen for storage prior to infusion as a liquid "slurry" enema directly into the rectum, Paramsothy said. Multiple donations were needed to supply the 40 infusions required for each participant receiving stool transplants, who administered their own infusions after the first treatment.
"There is a risk of infection transmission whenever a biological product is [used]," he said, "but this can be minimized by comprehensive screening of history [and] stool and blood testing for known pathogens."
After eight weeks, 27 percent of stool transplant recipients achieved the study's primary goal, which was patients reporting no ulcerative colitis symptoms and doctors determining through endoscopic examination that the lining of the colon had healed or significantly improved. Only three of the 40 patients, or 8 percent, in the placebo group had achieved this goal.
When researchers counted only those patients who reported being symptom-free, without colon observation, they found that 44 percent of stool transplant patients reached this milestone, compared to 20 percent in the placebo group.
The study is to be presented Monday at Digestive Disease Week, in San Diego. Research presented at scientific conferences typically hasn't been published or peer-reviewed, and results are considered preliminary.
Still, a U.S. expert said he found the results remarkable.
"I was most impressed . . . and I think we need to pay attention to this study," said Dr. R. Balfour Sartor, director of the Broad Research Medical Program for the Crohn's and Colitis Foundation of America. "There's a 'yuck' factor with stool transplants, although it's quite trendy these days. The clinicians, the patients and the government agencies have to be convinced it's safe and effective, and this study is probably the best example it can be for ulcerative colitis."
But more research is still needed to determine the treatment's long-term effects in ulcerative colitis patients, Paramsothy and Sartor agreed.
"What's not shown here is the staying power -- how long do these patients remain in remission after the eight weeks of therapy is over?" Sartor asked. "One of the defects of the current study is we don't know what happened after the fecal transplants stopped."
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases offers more about ulcerative colitis.
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