Probiotics for Clostridium Difficile Infection in Older Adults
Probiotics for Clostridium Difficile Infection in Older Adults
The purpose of this study is to determine whether a probiotic, when used together with
 standard treatment, is effective in reducing duration of symptoms and preventing recurrence
 of infection in older adults with a first episode of C. difficile infection.
Probiotics are live microorganisms that are available over the counter, widely used as
 dietary supplements or nutritional foods, and represent a low-cost, well tolerated, safe,
 non-antibiotic based strategy that may have efficacy as adjunctive treatment of infections
 without the attendant risks of promoting antimicrobial resistance. Certain probiotics have
 demonstrated inhibition of adherence of pathogenic bacteria and stimulation of systemic
 immune functions, possibly enhancing the body's ability to eradicate C. difficile in the
 gastrointestinal tract. However, limited data is available on the efficacy of probiotics for
 ameliorating C. difficile symptoms and reducing recurrence of C. difficile infection (CDI).
 The investigators propose a pilot randomized, double-blind, placebo-controlled clinical trial
 in older adult inpatients with a first episode of CDI to evaluate the efficacy of a probiotic
 combination, in conjunction with standard treatment, for reducing duration of diarrhea and
 recurrence of CDI.
Inclusion Criteria:

 -  Adult of either gender, 18 years or older with a first episode of C. difficile
 infection

 -  Meets the case definition of C. difficile infection-diarrhea associated with a
 positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment
 treated with metronidazole or vancomycin

 Exclusion Criteria:

 -  Severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm^3,
 elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile
 infection diagnosed

 -  Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal
 disease)

 -  Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)

 -  Has a presence of toxic megacolon or ileus

 -  Has a presence of colostomy or nasogastric tube

 -  Has a history of abdominal surgery within the previous 3 months (from time of
 enrollment)

 -  Is enrolled in another investigational drug trial

 -  Is unavailable for follow-up visits

 -  History of multiple C. difficile infection

 -  Willing not to take other probiotics for duration of study

 -  Is severely immunocompromised.