UPI Health News recently reported that a study, published in the New England Journal of Medicine, showed that fecal microbiota transplantation resulted in a 32 percent remission rate in patients with ulcerative coliltis.
Ulcerative Colitis (UC)
Ulcerative colitis is an inflammatory bowel disease (IBD) where the inner lining of the rectum and large intestine are inflamed. The exact cause of UC is unknown. However, genetic and environmental factors are suspected to increase the risk of the disease. Other risk factors assumed to be related to the onset and development of IBD are changes in the composition of the gut microbiota (meaning gut flora or gastrointestinal microbiota). The human microbiota may have between 10 trillion to 100 trillion microbial cells and over 1,000 species of microorganisms.
Bowel diseases such as Crohn’s or ulcerative colitis, have been diagnosed in approximately three million people in the United States, most often accompanied by various other diseases such as cardiovascular, respiratory, kidney and liver disease.
Symptoms of Ulcerative Colitis
Symptoms of UC, range from mild to severe and may include:
- Abdominal pain and discomfort
- Blood or pus in the stool
- Frequent bowel movements
- Weight loss
- Frequent, recurring diarrhea
- Tenesmus: A sudden and constant feeling that you have to move your bowels.
Note that these symptoms are also found in Crohn’s disease. UC has been successfully suppressed by current treatments but patients often relapse and experience side effects such as infection or malignancy.
About the Study
The randomized study involved 73 adults with mild-to- moderate active UC in a double-blind clinical trial conducted at three Australian referral centers. The goal of the study was to determine if fecal transplant, compared to a placebo, can induce clinical remission.
The trial began June 2013 and ended June 2016 with a 12- month follow-up through June 2017. One arm received anaerobically prepared pooled stools from multiple donor FMT. Study leader Sam Costello, a gastroenterologist at The Queen Elizabeth Hospital at the University of Adelaide’s Medical School, in a recent news release, explained anaerobic stool processing. “The most important difference in this trial compared to previous studies is the use of anaerobic (oxygen-free) stool processing. Many gut bacteria die with exposure to oxygen and we know that with anaerobic stool processing a large number of donor bacteria survive so that they can be administered to the patient.”
The second group (the control group) received autologous FMT. Treatment for both groups was administered via colonoscopy. The control group received standard of care (maintenance) for UC and also received their own feces. Maintenance for the control group involved medication to prevent flareup with continuous assessment.
Results of the Study
Of the 73 UC randomized patients, 38 received donor FMT and 35 received autologous FMT. After four patients left the study during the eight week observation period, the primary end point of steroid-free remission was achieved by 32% of patients in the pooled donor FMT versus 9% in the autologous FMT. Serious adverse advents were similar in both groups (3 in donor FMT and 2 in autologous FMT).
The study proved that anaerobically prepared pooled donor FMT is more effective than the autologous FMT, as in eight weeks it induced both clinical and endoscopic remission.
Microbiotica, a UK company, will be promoting additional R&D of a microbial therapeutic from this clinical trial.