By TAP Integrative

Fecal Microbiota Transplantation (FMT) refers to a procedure that involves collection of stool from a healthy donor, preparation of the stool, and administration via endoscopy, colonoscopy, enema, or capsules to the digestive tract of the patient. The goal of FMT is to establish a healthy intestinal microbiota in the patient. In the United States, FMT is currently approved only for the treatment of recurrent or refractory Clostridium difficile infection (rCDI).

Human clinical trials have demonstrated that FMT is highly effective in treating rCDI. A randomized clinical trial published in The New England Journal of Medicine in 2013 showed that duodenal infusions of FMT cured 90% of patients with rCDI. A study published in the Journal of the American Medical Association (JAMA) in 2016 then established the noninferiority of frozen to fresh FMT preparations. FMT is administered in medical centers in the United States, Germany, and around the world, but standards regarding its preparation and administration are lacking.

In order to evaluate the status of FMT in Germany as well as its clinical efficacy and safety, the German Clinical Microbiome Study Group created the MicroTrans Registry. The results of the registry’s first data set were presented in an article published by Hagel and colleagues in 2016.

This retrospective, multicenter, observational study included data from 133 patients who were treated with FMT for rCDI at 33 medical centers in Germany between 2014 and 2016. The majority of patients were female (65%), and the mean patient age was 75 years. The most common route of FMT administration was via the duodenal route (45%), followed by colonic (42%), capsule (10%), and gastric (3%). Primary cure on day 30 was achieved in 84% (101/120) of patients, and on day 90 in 78% (79/92) of patients. Response rates were similar in patients with or without antibiotic induction and in those with or without preparatory bowel lavage. There was a trend toward improved response when FMT was administered via the lower gastrointestinal route. Adverse events were reported in 12% (16) of patients, but none were severe or lethal.

The authors conclude that FMT protocols differ substantially among medical centers in Germany. To ensure the highest level of safety and efficacy, standardized protocols are needed for selection of eligible patients, donor screening processes and administration of FMT. This is important as this study confirmed that while most patients received treatment through the upper intestine, there was a trend towards higher response rates associated with treatment through the lower intestine.


Reference

Hagel S, Fischer A, Ehlermann P, et al. Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection. Dtsch Arztebl Int. 2016;113(35-36):583-589.


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