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Utah doctor seeking patients to test vaccine to prevent potentially debilitating infection

A Utah doctor is looking for patients to enroll in a worldwide clinical trial that could lead to the approval of a new vaccine to prevent clostridium difficile colitis — C. diff — an often debilitating and potentially fatal illness.
A Utah doctor is looking for patients to enroll in a worldwide clinical trial that could lead to the approval of a new vaccine to prevent clostridium difficile colitis — C. diff — an often debilitating and potentially fatal illness.
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SALT LAKE CITY — Patients often go to the doctor with one problem, but come out with a completely different one, thanks to a nasty bacterial infection that can so easily grab hold of the gut.

"It's fairly common," said Dr. Derek Muse, a local family practitioner who is participating in ongoing research to develop a vaccine to prevent clostridium difficile colitis — or C. diff for short. "Some people get it, get diarrhea and other moderate symptoms and it goes away in about three weeks. In older patients, it becomes more severe and can result in death."

C. diff has been called an "urgent threat to the public," causing an estimated half-million infections and at least 29,000 deaths in the United States in 2011, according to the U.S. Centers for Disease Control and Prevention. Rates of infection increased 400 percent from 2000 to 2007, as more dangerous strains emerged and it has become more difficult to treat.

Clostridium difficile is a bacteria found in feces. People taking antibiotics are more prone to picking it up, transmitting it from hand to mouth, as many of a person's protective measures are depleted during antibiotic treatment.

Muse said about half of the cases of C. diff occur in people younger than 65, but those in people age 65 and older account for 95 percent of deaths related to the infection. Symptoms include diarrhea, fever, nausea and other abdominal issues that can lead to a perforated colon and bacteria leaking into the bloodstream.

"With this vaccine, we're trying to reduce the chances they'd come down with this potentially virulent infection," Muse said.

People most at risk for developing the infection include anyone who takes antibiotics, which includes patients who are hospitalized for any number of reasons, as well as those who are scheduled for various surgeries.

The clinical trial being offered by Muse, a medical director for Jean Brown Research, aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

"Our hope is that they'd be protected for their lifetime, but we just don't know that yet," Muse said. "It's something that would be evaluated by the results of the trial."

The trial, sponsored by global pharmaceutical company SanofiPasteur, needs 15,000 enrollees across 20 countries throughout the world to reach statistical significance. The company has successfully developed vaccines for tetanus, typhoid, pertussis, rabies and more. It also manufactures the influenza vaccine most commonly used in the market today.

To be eligible for the clinical trial to evaluate effectiveness against C. diff, patients must be age 50 or older, hospitalized twice in the past year for 24 hours or more, and/or planning to have an upcoming surgical procedure. Muse said the study doesn't guarantee participants will receive the active vaccination, as placebos are used to confirm the research.

"We're trying to bring very helpful medications to the market and that requires a lot of volunteers," he said. "In the end, we ask patients to sacrifice a little bit of their time to participate in these studies and some medications end up saving millions of lives all over the world."

A number of vaccines come out each year, including one for meningitis that became available earlier this year. An update of the human papillomavirus vaccination, as well as one to help the elderly avoid pneumonia are also newly available.

"These things cause so much suffering," Muse said. "Doctors want these vaccines yesterday."

Muse blames over-prescription of antibiotics for the growing number of cases of C. diff. Antibiotics, he said, can destroy the normal bacteria in the intestine, which can result in overgrowth of toxic spores that can injure the lining of the colon and cause diarrhea, abdominal pain and bloody stool.

The key, he said, is preventing C. diff altogether.

"Talk with your doctor whether you really need an antibiotic or not," Muse said. "Many upper respiratory infections don't need antibiotic treatment. Even mild sinus infections don't have to be treated."

Antibiotics, unless necessary, should be deferred or delayed until necessary, the Highland Family Practice doctor added.

Treatment, if caught early enough, can include another regimen of antibiotics and recent findings show that introducing healthy volunteer stool can also have a productive impact in clearing the infection. Fecal matter transplantation procedures, however, are still being researched and it is not yet available in Utah, according to the Fecal Transplant Foundation. A number of facilities across the country, however, are collecting and compensating people for healthy stool donations.

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

Email: wleonard@deseretnews.com; Twitter: wendyleonards