Fecal Transplants: A Clinical Trial Confirms How Well They Work

Maryn McKenna in Wired:

A little more than a year ago, I wrote a piece in Scientific American about fecal transplants — replacing the stool in someone’s colon with stool donated by someone else — as a treatment for the pernicious, recurrent diarrhea caused by Clostridium difficile infection. I have been a journalist for two decades, and some of my stories have won prizes, triggered hearings and legislation, and caused people to change their minds about significant social issues — but I don’t think anything I have written has ever proved as sticky with an audience as that 1,500-word column. In the 60 or so weeks since it was published, I have heard from more than 100 people — yes, that’s more than 1 per week — who are afflicted with C. diff, believe that a transplant could help them, but cannot find a doctor who agrees that the procedure has merit. A paper published Wednesday evening in the New England Journal of Medicine may give those patients assistance, and change those doctors’ minds. It represents the first report from a completed randomized trial of fecal transplants, and it finds that the treatment worked much better than the powerful antibiotics that are usually given for C. diff infection — so much better, in fact, that the trial was ended early, because the monitoring board supervising the trial’s execution could not ethically justify withholding the transplants from more patients.

Here are the details: A group of Dutch and Finnish researchers enrolled patients with severe C. diff (defined as at least one relapse of infection after antibiotic treatment, plus at least three bouts of diarrhea per day or eight over two days) into three groups, who received either a fecal transplant, or one of two comparative treatments: either the standard course of vancomycin, a broad-spectrum, last-ditch antibiotic, for two weeks; or the same antibiotic course with bowel lavage (a high-volume enema that reaches deep into the colon and is used to clean things out before transplanting stool) added on the fourth or fifth day of taking the drugs. The fecal transplant was donor stool, screened for parasites and infectious organisms, diluted and strained, and given by a tube that snaked up through the nose and down through the stomach to the start of the intestine.

...Of 16 transplant patients (one was excluded for reasons unrelated to the trial), 13 were cured on their first infusion, and two more on a repeat round, making the transplant 94 percent effective. In the two drug arms, the rates were 31 percent in the vancomycin-only group (4 of 13) and 23 percent (3 of 13) in the group receiving vancomycin plus lavage.

More here.