A study recently published in the Journal of Translational Medicine showed that fecal microbiota transplantation may represent a promising therapeutic approach for patients with ulcerative colitis. The study is entitled “Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis” and was conducted by researchers from several institutes in China.
Ulcerative colitis is a type of chronic inflammatory bowel disease (IBD) characterized by inflammation in the colon, formation of ulcers (tiny open sores), abdominal discomfort and diarrhea with blood. The condition is thought to be the result of an abnormal response by the body’s immune system, and the intestinal microbiota is also believed to play a role on disease development.
Current treatment strategies for ulcerative colitis are based on the promotion of disease remission, with corticosteroids being the most effective treatment option for patients suffering with moderate to severe ulcerative colitis. Unfortunately, steroids are known to cause undesirable side effects, like bone loss, hyperglycemia and infections. Therefore, new steroid-free therapies are needed for ulcerative colitis patients.
Fecal microbiota transplantation (FMT) is a concept developed in China and based on the infusion of healthy donor microbiota into the intestines of the patient in order to restore his/her intestinal microbiota. Studies have suggested that a single FMT can have some therapeutic effect in IBD patients, including ulcerative colitis patients.
In the study, researchers hypothesized that repeated FMT interventions, alone or combined with a short-term corticosteroids therapy, could improve the treatment efficacy of ulcerative colitis.
The team developed a protocol to conduct a FMT therapeutic intervention for the treatment of steroid-dependent patients with ulcerative colitis. They established a standard bacteria isolation procedure to obtain purified fecal microbiota, which could be subsequently transplanted into the mid-gut of patients through a regular gastroscope.
The research team assessed the safety and efficacy of their FMT strategy in a clinical trial (NCT01790061), and characterized the composition of the fecal microbiota that allowed a sustained positive clinical response. In total, 15 steroid-dependent patients with ulcerative colitis were enrolled in the study, and 14 were followed up for at least 3 months after FMT intervention.
Researchers found that 57.1% of the patients analyzed (8 out of 14) had a clinical improvement after FMT intervention and could discontinue steroid therapy. Among these 8 patients, 5 had received a single FMT therapy, 1 patient received two FMTs, and 2 patients received two FMTs combined with a scheduled course of steroids. Of these 8 therapy-responsive patients, 4 maintained long-term disease remission in the follow-up period (3 to 18 months). The analysis of the microbiota revealed that FMT intervention significantly changed its composition, namely through the decrease in Proteobacteria and the normalization of the Firmicutes to Bacteroidetes ratio, and that patients who experienced successful treatment exhibited a microbiota very similar to the one used as donors in FMT. In terms of safety, no severe adverse events were reported.
The researchers concluded that their established FMT strategy might represent a promising therapeutic approach for patients with steroid-dependent ulcerative colitis. The authors believe that a proper re-structuring of the gut microbiota in this patient population is a key treatment strategy. The team is currently involved in a study evaluating FMT in combination with other IBD therapies.
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