Hospital study results highlight the dramatic reductions in incidence of Clostridium difficile diarrhea diagnoses that are possible when Florajen3 is added to therapy of hospitalized patients receiving antibiotics.
SCIENTIFIC BRIEF
Florajen3 Prevents Antibiotic-
Associated Diarrhea in Hospitalized Patients
A common side effect of antibiotic therapy is diarrhea. Antibiotic-associated diarrhea is estimated to affect 11-40% of people taking antibiotics, and nearly all antibiotics can cause diarrhea. Antibiotic-associated diarrhea may occur while an individual is taking antibiotics or up to 2 months after a course of antibiotics has concluded. Most of the time, a specific microbial cause for AAD is not found. However, in severe cases, the bacterium, Clostridium difficile is often found to be the underlying cause. During antibiotic treatment, disruptions of gastrointestinal flora occur in which many populations of normal gut bacteria, including organisms believed to keep Clostridium difficile growth and activities in check, are dramatically reduced. Unfortunately, most antibiotics are incapable of eradicating Clostridium difficile, especially the spore form of the bacteria. Thus, as an opportunistic microorganism, Clostridium difficile may overgrow in the intestinal tract as a consequence of exposure to antibiotic medications and inadequate healthy normal flora to suppress its actions.
Hospitalized patients, especially those receiving antibiotic therapy are especially prone to developing Clostridium difficile diarrhea. Recently, this bacterium caused diarrheal outbreaks in several Canadian hospitals and was responsible for over 100 deaths. Clostridium difficile disease frequently extends hospital stays for affected patients (by 3-7 days) resulting in higher hospital costs (up to $1 billion per year). The microorganism has been associated with relapses (20%) or subsequent reoccurrence of infections (20-65%) and increases mortality 2-3 fold.
Currently, placing affected patients in isolation and utilizing good hand hygiene (ie. hand-washing between patients) are measures utilized by most hospitals to curb infections caused by Clostridium difficile. However, the strategy of a Mesa, Arizona, hospital also relies upon probiotics.
Probiotics are live microorganisms—often the same types of bacteria normally found in healthy gastrointestinal tracts. Probiotics may restore the balance of “good” bacteria in the digestive system and keep Clostridium difficile from over-growing.
In 2001, Valley Lutheran Hospital (now called Banner Baywood Medical Center) decided to investigate just how effective Florajen3 (Lactobacillus acidophilus, Bifidobacteria bifidum, and Bifidobacteria longum) might be for preventing Clostridium difficile diarrhea.
A protocol was developed such that all hospitalized patients at Valley Lutheran Hospital who were prescribed antibiotics also received Florajen3. A dose of one Florajen3 capsule was to be administered three times daily to all patients receiving antibiotics, including post-operative patients who were not able to eat food by mouth. Medical records were retrospectively reviewed on a monthly basis to determine the incidence of Clostridium difficile diarrhea diagnosis, as well as the impact that the infection had on length of hospitalization. Data were collected for 3 month time periods (February through April) during three consecutive years (1999, 2000, and 2001).
In 2001, once Florajen3 was included as part of patient’s therapeutic regimens, the incidence of Clostridium difficile diarrhea decreased from baseline by 60% (from 40 or 41 cases during 1999 and 2000, respectively, down to 16 cases in 2001). Furthermore, this reduction in Clostridium difficile infectivity also correlated with shorter hospital stays. The average length of stay in the hospital decreased from 9.75 days in 1999 and 9.53 days in 2000 to 7.43 days in 2001. Another way to look at the data is to consider the total number of days that patients with Clostridium difficile required hospitalization. Compared to 1999 and 2000, the total number of days in the hospital was reduced by 70% for those receiving Florajen3.
At a nearby sister hospital, where probiotics were not administered, the overall diagnosis of Clostridium difficile did not change between 1999 and 2001. Data from another hospital within the same health system illustrates that the number of Clostridium difficile cases held steady at this institution during the study period. Moreover, the length of hospitalization actually increased during this time period for those affected by Clostridium difficile. This is most apparent between 1999 and 2001 in which the total number of days that patients with Clostridium difficile remained hospitalized was 353 days in 2001 versus 262 days in 1999.
Perhaps most importantly, the total number of patients discharged from both hospitals increased steadily each year. At Valley Lutheran Hospital, not only was there a 60% reduction of Clostridium difficile diagnosis in 2001 compared to baseline, but the number of patients treated by the hospital that year increased by 21%. This brings the Clostridium difficile infection rate down to only 0.33% of patients admitted—representing a 68% improvement in diarrheal prevention from 1999, simply by including probiotics in the therapeutic regimens of hospitalized patients that were prescribed antibiotics.
Interestingly, the compliance rate for patients receiving probiotic therapies as prescribed was only 60%. If compliance had been higher, the benefits of Florajen3 for preventing Clostridium difficile diarrhea might have been even more dramatic.
To our knowledge, this is the first published study to examine outcomes of Florajen3 in hospitalized patients prescribed antibiotics. These results highlight the dramatic reductions in incidence of Clostridium difficile diagnoses that are possible when Florajen3 is added to therapy of hospitalized patients receiving antibiotics.
The complete clinical study, “Lactobacillus and Bifidbacteria combinations: A strategy to reduce hospital-acquired Clostridium difficile diarrhea and mortality” by Terry Graul, Alisha M. Cain and Kelly D. Karpa, was published in Medical Hypotheses, February, 2009.
