Fecal Transplantation Proving Highly Effective

Repopulating a patient’s intestines with healthy microbiota can eliminate C diff –associated diarrhea virtually overnight.

“You see dramatic improvement from day 1 to day 3. It’s a drastic turnaround that changes patients’ lives,” says Cleveland Clinic Florida gastroenterologist Alison Schneider, MD.

Since late 2013, Dr. Schneider and Bret Lashner, MD, her colleague on Cleveland Clinic’s main campus, have treated about 150 patients with this unconventional approach with an efficacy rate of about 95 percent. No adverse events have occurred.

The procedure can be a quality-of-life-saver on patients who have contracted the bacterial infection for any reason, including immune suppression for organ transplantation, irritable bowel syndrome and ulcerative colitis.

FDA holding the line

Cleveland Clinic’s programs in Cleveland and Florida follow a single IRB-approved protocol for performing fecal microbiota transplantation (FMT) that requires obtaining patient consent. At this time, the FDA restricts the treatment to recurrent or refractory C difficile infection.

“FMT is considered a biologic therapy by the FDA, so an investigational new drug (IND) application is required for all new indications,” Dr. Lashner explains. “Since it works so well in C difficile colitis, the FDA announced there will be ‘enforcement discretion’ for FMT in patients with C diff. IND applications are not required for this indication.”

Multiple clinical trials of FMT for ulcerative colitis, inflammatory bowel disease (IBD), diabetes, coronary artery disease, and other conditions are being conducted.

Lessons learned

In most patients who undergo fecal transplantation, resumption of normal stool signifies the C diff infection has been cured. In some cases, however, the treatment eliminates the C diff, but not the diarrhea. “In these cases, the diarrhea is likely due to ulcerative colitis or other cause,” says Dr. Lashner. “We don’t test the stool afterwards, but we return the patient to the referring physician with a suggestion that a fecal analysis be conducted.”

Selected patients may require more than one treatment. One Cleveland Clinic Florida patient suffered a recurrence one year later and was retreated successfully.

One differentiating aspect of Cleveland Clinic’s program is that a stool bank is not used. Fecal donors must be consented and screened. Infection, IBD, cancer, autoimmune disease, chronic pain, metabolic syndrome, obesity and recent antibiotic use are contraindications to donation. “There may be a connection between many of these diseases and the gut microbiome, and we want the healthiest donor possible,” says Dr. Schneider.

Not the last word

Despite the success of fecal transplantation, different treatment approaches may ultimately replace it.

Several companies have developed tasteless pills that encapsulate the desired microbiota. After being swallowed, these pills dissolve when they reach the small bowel. No colonoscopy would be required with this method, which is still in early clinical trials.

“It’s a good concept and may be the way of the future, but for now, fecal transplantation does the job. We do it well, and our patients get better,” says Dr. Schneider.