The study is published in the May 5 issue of the Journal of American Medical Association (JAMA) and is the focus of a JAMA-produced video.
“The results of this study are very gratifying because the preclinical laboratory and patient studies were all done through our VA research program supported by the Department of Veterans Affairs Research Service,” says Gerding. “Results of this study confirm findings of earlier studies that showed that if we can establish non-toxic Cdiff as a resident of the gut of the patient, that we can protect the patient from infection by the toxic strains of Cdiff.” Viropharma and Shire pharmaceutical companies supported the clinical trials.
These results warrant additional study to confirm that treatment with non-toxic Cdiff spores can reduce recurrent Cdiff infection and prevent a first episode of Cdiff infection in those who are taking any antibiotics and are at high risk of infection, he added.
Gerding and an international team of infectious disease researchers, including those at Loyola University Medical Center (LUMC), randomly assigned 168 adult patients with Cdiff infection who had been treated for their infection with antibiotics to receive doses of 10 thousand or 10 million spores per day of non-toxic Cdiff in liquid form for 7 or 14 days, or to receive an identical placebo. Of those assigned any dose of non-toxic Cdiff , 11 percent experienced a repeat of infection within 42 days compared with 30 percent of those given a placebo, a statistically significant reduction. For the most favorable dose tested, 10 million spores a day for 7 days, the recurrence of Cdiff infection was reduced to 5 percent.
Hospital-acquired infections (HAI) including Cdiff, which causes severe diarrhea and inflammation of the lower bowel or colon, continues to escalate in frequency and severity in the U.S. According to the Centers for Disease Control and Prevention (CDC), almost 500,000 Cdiff infections occurred in the U.S. in 2011, with 83,000 recurrences and 29,000 deaths within 30 days of diagnosis. Older adults taking antibiotics and who receive care at medical institutions are most vulnerable.
Cheryl O’Riordan, who has had repeated bouts of Cdiff infection, said having Cdiff made her visit the bathroom on an average of 10 times per day. “Before receiving effective treatment, I was unable to leave the house,” says the active cyclist, skier and hiker. O’Riordan went into remission after being treated successfully at LUMC. “I am back cycling more than 3 miles every day and have several major adventure trips planned.”
Gerding, who has published more than 135 studies on Cdiff is considered one of the leading international experts on Cdiff. (Watch an interview where Gerding discusses the study.)
Stuart Johnson, MD, infectious disease specialist at LUMC, is also the director of research at Hines VA hospital. Together Gerding and Johnson have partnered on Cdiff research for almost three decades, involving many LUMC patients.
“The study offers real hope for those debilitated by recurring bouts of Cdiff,” says Johnson, who cares for O’Riordan at LUMC in Maywood. “This study represents a novel and potentially highly effective bacteriotherapy approach to restoring colonization resistance against toxic strains of Cdiff in these patients,” he adds.
Loyola University Health System is recognized internationally as a leader in infection control and prevention.
LUMC is one of a few select hospitals who invest in universal screening of all inpatients for MRSA. Loyola was one of the first institutions to require all staff to have mandatory flu shots as a condition of employment. Loyola was one of several academic hospitals that participated in this recent benchmark international study.
Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children’s Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola’s Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.