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.

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Clostridium difficile accounts for 15-25% of all episodes of antibiotic-associated diarrhea.

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.

The aim of this study was to evaluate the safety and rate of diarrhea resolution associated with oral administration of the capsule for patients with recurrent CDI.

Dr. Ilan Youngster, of Massachusetts General Hospital in Boston, and colleagues recruited 20 patients, aged 7-90 years with three or more episodes of mild to moderate CDI. A failure of a 6- to 8-week symptom reduction with oral vancomycin antibiotic or at least two episodes of severe CDI requiring hospitalization was also part of the inclusion criteria.

Patients received 15 capsules on 2 consecutive days, with monitoring of symptom resolution or occurrence of adverse events for up to 6 months.

No serious adverse events were observed, and findings among the 20 patients showed:

  • A clinical resolution of diarrhea in 14 patients after the first administration of capsules, remaining symptom-free at 8 weeks
  • Of the six nonresponders, four obtained resolution of diarrhea after a second administration performed 7 days after the first
  • Bowel movements decreased from a median of five a day to two at day 3, and one at 8 weeks
  • Self-reported health rating on a standardized questionnaire improved from a median of 5 for overall health and 4.5 for gastrointestinal health to 8 for both at 8 weeks after administration of capsules.

There was an overall 90% rate of clinical resolution of diarrhea.

The authors say:

If reproduced in future studies with active controls, these results may help make FMT accessible to a wider population of patients, in addition to potentially making the procedure safer.”

They add, “The use of frozen inocula allows for screening of donors in advance. Furthermore, storage of frozen material allows retesting of donors for possible incubating viral infections prior to administration. The use of capsules obviates the need for invasive procedures for administration, further increasing the safety of FMT by avoiding procedure-associated complications and significantly reducing cost.”

The authors state that the main limitations of the study are the small sample size and lack of placebo or active comparator. They note that larger studies are needed to confirm the results and to evaluate long-term safety and effectiveness of the capsule.

Medical News Today recently reported C. difficile to be treated with “bacteria-eating viruses” – a team of scientists from the European Molecular Biology Laboratory in Hamburg, Germany, found a new way to treat C. difficile bacteria – by using viruses to “eat” them.