Fecal Microbiota Transplantation Deemed Safe and Effective

New research found that fecal microbiota transplantation is a safe and effective treatment option for patients who have an infection of the bowel with recurrent Gram-positive bacillus Clostridium difficile (C. difficile).

Findings from the retrospective, multi-center, longitudinal observation study were published in Deutsches Ärzteblatt International. The response rates to fecal microbiota transplantation as a treatment for recurrent C. difficile infection were determined at 30 and 90 days, and adverse events were registered.

The results of the study showed that primary cure was achieved at 30 days in 101 of 120 patients (84.2%), and at 90 days in 72 of 92 patients (78.3%). After the second microbiota transplant was performed in 19 patients, the figures improved further.

There were no reports of severe adverse effects or deaths within 30 days of the treatment. Currently, fecal microbiota transplantation has not been approved by the regulatory authorities, and can only be used in Germany as an individual treatment for C. difficile infection if all other treatments are unsuccessful.

Study authors are calling for more uniform documentation of the clinical safety and efficacy of fecal microbiota transplantation. Additionally, diverse protocols for patient selections, donor screening, and the processing and application of stool samples need to be harmonized for better quality assurance, according to the study.