Rather than treating recurrences of the spore-producing superbug C. diff with antibiotics, scientists Wednesday proposed a cocktail of nontoxic spores, which they say may be curative.
The unusual therapy, reported in the Journal of the American Medical Association, is the latest strategy against a microbial menace that has invaded health care facilities worldwide.
The treatment requires patients to drink a fluid containing either 10,000 Clostridium difficile spores or as many as 10 million for seven days. The nontoxic spores allow the intestinal tract to re-establish healthy flora, doctors say.
"If it works, it works. And I never argue with success," said Dr. Noel Kleppel of Lawrence, who was not involved in the research but is among the world's pioneers in treating patients whose intestinal bacteria have been destroyed by aggressive drug-resistant species.
Kleppel, an associate professor on staff at SUNY Downstate Medical Center in Brooklyn, published a paper on "fecal feedings" in 1959.
Spore-laced cocktails arrive on the heels of yet another approach, involving so-called "poop pills" -- encapsulated fecal bacteria, which patients swallow to aid re-establishment of healthy intestinal bacteria.
A study of the capsules was published last month in the journal BMC Infectious Diseases by a team of medical investigators at North Shore University Hospital in Manhasset.
Lead author Dr. Bruce Hirsch also held a grand rounds presentation at the hospital last month to discuss C. diff and poop pills with other doctors. Grand rounds are time-honored teaching sessions in hospitals. Doctors present data on pressing medical concerns. "We are using a form of poop pills -- cryopreserved-concentrated fecally derived bacteria," he said of the orally administered capsules.
New strategies are under investigation because C. diff is a major public health concern and escalating antibiotic use has created deadly forms of the microbes. In New York alone, there were nearly 20,000 C. diff cases tabulated in the most recent Hospital-Acquired Infections report by the state Health Department.
Hospital-acquired infections are a significant cause of sickness and death, according to the Centers for Disease Control and Prevention, which estimates annual costs between $28 billion and $45 billion. Each year nationwide, about 2 million people contract drug-resistant microbes and 23,000 die as a direct result.
Doctors at Loyola University Chicago's Stritch School of Medicine led the nationwide study involving C. diff spores. The team divided its 173 patients into groups, each receiving different spore doses. All spore-drinkers were compared with patients who received antibiotics, standard therapy.
The research cited a need for new treatments because up to 30 percent of patients who contract C. diff have a recurrence.
Infection can cause severe diarrhea and fever; in some people, C. diff proves lethal.
Infections "are caused by an overuse of antibiotics," said Dr. Vincent Yang, who chairs the department of medicine at Stony Brook University School of Medicine.
"It's becoming a very common infection in the community, particularly in nursing homes," Yang said, adding that concern is mounting in the medical community because of the emergence of more virulent, toxin-producing C. diff variants that are harder to treat. One strain, NAP-1, is multidrug-resistant and produces more toxins than other forms of C. diff.
"It is very problematic," Yang said.
He hailed the nontoxic spore therapy as promising and underscored that the study, which was conducted at 44 medical centers around the country, was a randomized, double-blind, placebo-controlled analysis, which is considered the gold standard in scientific research.
Kleppel, however, said he would like to see a larger clinical study involving more patients.
Hirsch also had concerns. "The nontoxigenic C. diff spore approach fails to address the central issue with these patients: The normal bacteria in the lower GI [gastrointestinal] tract . . . are profoundly disturbed." The spore-cocktails do not correct the problem that leads to recurrences, Hirsch said.