A preliminary study published in JAMA demonstrates the potential of treating recurrent Clostridium difficile infection with frozen encapsulated fecal matter administered orally.
Clostridium difficile (C. difficile) is a bacterium that affects the digestive system and can lead to severe swelling of the bowel and inflammation of the colon. Recurrent Clostridium difficile infection (CDI) is considered a major cause of illness and death globally, with a recent significant increase in the number of both adult and child patients affected.
Symptoms of C. difficile are unpleasant and can include:
Watery diarrhea (three or more bowel movements per day for 2 or more days), sometimes blood-stained
Fever
Loss of appetite
Nausea
Abdominal pain or tenderness.
C. difficile produces spores that are passed out the body in feces and can survive for many weeks, sometimes months, on surfaces, devices or materials. The bacteria can then be spread by anyone who comes into contact with the contaminated surface.
C. difficile accounts for 15-25% of all episodes of antibiotic-associated diarrhea. The standard treatment of the infection is with an appropriate course of antibiotics such as metronidazole or vancomycin - these have been increasingly associated with treatment failures with the infection returning in around 20% of patients.
A procedure called fecal microbiota transplantation (FMT), consisting of transplanting the stool from a healthy related donor to the infected individual has previously proven effective at eradicating the infection, relapses and restoring healthy gut microbiota. Practicalities and safety concerns have prevented widespread use of this process.
These concerns have been overcome in the study by the researchers' use of frozen fecal matter from thoroughly screened healthy donors who were unrelated to the infected patients. Donors were healthy, non-pregnant adults aged 18-50 years, taking no medications, and with a normal body mass index (BMI).
Researchers generated a capsulized version of the frozen stool matter to be administered orally to remove the need for invasive gastrointestinal procedures as with the previous study.