Pittsburgh, PA based Allegheny Health Network (AHN) today announced a new resource for patients with treatment-resistant Clostridium difficile (C. diff) infections who may benefit from fecal transplant therapy.

Clostridium difficile Image/CDC
Clostridium difficile

AHN is the first medical center in the region to provide patients with access to pre-screened samples from an FDA-approved stool bank, eliminating many of the obstacles in the fecal transplant process, according to Kofi Clarke, MD, Chief, Division of Gastroenterology, Allegheny Health Network.

C. diff is a potentially life-threatening, spore-forming bacterium. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiplies and releases potent toxins that can damage a patient’s intestinal lining.

Transplanting fecal matter from a healthy individual into the colon of a patient with C. diff can restore a healthy balance of the microorganisms that live in the digestive tract. AHN has offered fecal transplants for several years, but the process of finding and screening donors is time consuming and expensive.

“Finding a personal donor involves a large cost because each donor has to be screened,” said Dr. Clarke. “Screening can take weeks – and if something disqualifies the donor, you have to start all over.”

AHN has contracted with Massachusetts-based OpenBiome to acquire frozen, cultured and screened stool samples that can be stocked on-site and immediately accessible to patients who are very ill. The samples are shipped to AHN on dry ice and stored at -80 degrees until they’re needed.

Staff in the gastroenterology lab at Allegheny General Hospital (AGH) are trained in thawing and preparing the samples for transplant, which is done via colonoscopy.

AHN is one of 460 medical centers across the United States that currently purchases ready-to-use fecal preparations from OpenBiome.

The bank requires prospective donors to complete a rigorous screening process including a 109-question clinical evaluation with an internal medicine specialist and a battery of serological and stool-based tests to check for infectious pathogens. Less than 3 percent of prospective donors pass the clinical evaluation and stool and serological screens to become active OpenBiome donors.

Samples from pre-screened donors are a cost-effective alternative to identifying new donors and expedite the transplant process.
“This is something that can happen almost immediately for people who are very sick,” Dr. Clarke said.

According to the Centers for Disease Control and Prevention, approximately 500,000 Americans are infected with C. diff, and at least 14,000 fatalities are attributed to C. diff each year.

The most common symptoms of mild to moderate C. diff infection are watery diarrhea and mild abdominal cramping and tenderness. C. difficile causes the colon to become inflamed and sometimes may form patches of raw tissue. In severe cases, diarrhea and cramping worsen and may be accompanied by fever, nausea, loss of appetite, weight loss, swollen abdomen and kidney failure. People with severe C. diff tend to become dehydrated and may need hospitalization.

LISTEN:  Interview with OpenBiome Clinical Outreach Associate, Rodrigo Muñoz