Clinical trials focus on new treatments for Crohn's Disease, dangerous bacterium

March 20, 2012 By Katie Pence, University of Cincinnati

Several clinical trials at the University of Cincinnati (UC) are focused on potential treatments for two serious gastroenterological illnesses—Crohn’s disease and Clostridium difficile, or C. difficile.

Bruce Yacyshyn, MD, professor of medicine in the division of digestive diseases and principal investigator for the Cincinnati sites on both multicenter, international trials, says researchers are working with the pharmaceutical companies Janssen and Merck to find new therapies for a potentially life-altering autoimmune disease and for a condition, once only common in the autoimmune-compromised hospital population, that is now becoming an epidemic within the general population.

Yacyshyn says the first study—called UNITI-1—will examine how a Food and Drug Administration (FDA)-approved drug used for psoriasis may help in treating patients with Crohn’s disease who experience treatment failure with the other drugs commonly prescribed.

Crohn’s disease is an inflammatory bowel disease that occurs when the immune system attacks the gastrointestinal tract. Crohn’s can affect any part of the tract and inflame all layers of the intestinal wall; it most typically begins in younger years, with an average age of trouble occurring at 36.

Besides experiencing abdominal pain, bloody stools, diarrhea and other serious problems, such as growth failure because of a lack of nutrients, individuals with Crohn’s have an increased risk of colorectal cancer.

"There are currently three FDA-approved monoclonal biologic treatments for Crohn’s disease,” Yacyshyn says, explaining that these treatments are helpful because they target a pathway which activates the immune response in the body and produces the proteins that attack the gastrointestinal tract.”

"This clinical trial will focus on a therapy that will target a different pathway, giving hope to patients who have not experienced success with one of the other treatments or whose treatments begin to lose effect,” he adds.

The second clinical trial is looking at a single injection to see if this treatment could clear initial or recurrent onset of C. difficile.

C. difficile is a bacterium that can be naturally found inside the digestive tract, but if an overgrowth occurs, it can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Illness from C. difficile was once more common in older adults who were hospitalized or among people in long-term care facilities, and typically occurred after use of antibiotic medications.

"In recent years, C. diff infections have become more frequent, more severe and more difficult to treat,” says Yacyshyn, adding that treatment is expensive, ranging anywhere from $4,000 to $9,000. "Tens of thousands of people in the U.S. get sick from C. diff each year, and a rise in cases is being seen in the community—in healthy people who aren't hospitalized or taking antibiotics.”

In this Phase III trial, researchers will be giving individuals who currently test positive for C. difficile one of two antibodies which recognize the toxins produced by the bacteria.

"The infusion will be given with concurrent, standard-of-care antibiotic therapy. Following this one-time infusion, follow-up will occur over three months with a possible follow-up extension to nine months,” says Yacyshyn, adding that this is for patients 18 years or older. "There is currently no optimal treatment for all C. difficile-positive patients, and the antibiotics usually prescribed for it are not effective in all cases.  

"Addition of this treatment alongside current standard-of-care treatment may cut down on recurrence and help clear both toxin and bacteria after initial infection.

"While different, both of these conditions affect a large number of the population and could cause major complications if not treated properly,” he adds. "The hope is that these help in uncovering additional or more beneficial treatments for Crohn’s disease and C. difficile.”

Explore further: Single dose of antibiotic leaves mice highly vulnerable to intestinal infection

More information: Yacyshyn receives research support from Merck but cites no other conflict of interest.

Related Stories

Single dose of antibiotic leaves mice highly vulnerable to intestinal infection

January 20, 2012
Yet another study adds to the growing evidence that antibiotics can disrupt the balance of the intestinal flora, with negative effects on health. A team of researchers from the Memorial Sloan Kettering Cancer Center, New ...

Research identifies new way to treat common hospital-acquired infection

August 21, 2011
Researchers at the David Geffen School of Medicine at UCLA and the University of Texas Medical Branch at Galveston have discovered a molecular process by which the body can defend against the effects of Clostridium difficile ...

Recommended for you

New study offers insights on genetic indicators of COPD risk

January 16, 2018
Researchers have discovered that genetic variations in the anatomy of the lungs could serve as indicators to help identify people who have low, but stable, lung function early in life, and those who are particularly at risk ...

Previous influenza virus exposures enhance susceptibility in another influenza pandemic

January 16, 2018
While past exposure to influenza A viruses often builds immunity to similar, and sometimes different, strains of the virus, Canadian researchers are calling for more attention to exceptions to that rule.

Don't hold your nose and close your mouth when you sneeze, doctors warn

January 15, 2018
Pinching your nose while clamping your mouth shut to contain a forceful sneeze isn't a good idea, warn doctors in the journal BMJ Case Reports.

New antifungal provides hope in fight against superbugs

January 12, 2018
Microscopic yeast have been wreaking havoc in hospitals around the world—creeping into catheters, ventilator tubes, and IV lines—and causing deadly invasive infection. One culprit species, Candida auris, is resistant ...

Dengue takes low and slow approach to replication

January 11, 2018
A new study reveals how dengue virus manages to reproduce itself in an infected person without triggering the body's normal defenses. Duke researchers report that dengue pulls off this hoax by co-opting a specialized structure ...

Different strains of same bacteria trigger widely varying immune responses

January 11, 2018
Genetic differences between different strains of the same pathogenic bacterial species appear to result in widely varying immune system responses, according to new research published in PLOS Pathogens.

3 comments

Adjust slider to filter visible comments by rank

Display comments: newest first

Laurettas
not rated yet Mar 21, 2012
I believe the FDA has announced that PPI use can increase the chances of getting C diff. Since there are millions of people on PPI's, might that not be a contributing cause to C diff's increased cases?
vcb
not rated yet Mar 21, 2012
I am a Crohn's patient, when will this study start?
DDBear
not rated yet Mar 21, 2012
Why is Crohn's becoming more common in the general population? Probably because food makers are increasingly putting unhealthy ingredients such as corn syrup in just about every product and it is hard for people to avoid. The billions the government spends on taxpayer subsidies for corn (to produce corn syrup) is one of the biggest scandals that so far is receiving little attention.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.