Probiotics for Clostridium Difficile Infection in Older Adults

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.