Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
Clostridium difficle infection is the leading cause of hospital acquired infection and
 infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the
 challenging tasks for clinicians due to treatment resistance developed from new hypervirulent
 strains. The recurrence rate of this infection is around 20% and there is high
 likelihood(60-70%) of another episode after index recurrence. Given constant challenge new
 treatment options are under study. Aim of the study is to evaluate if use of bismuth
 subsalicylate (BSS) can decrease the length of stay in patients admitted with Clostridium
 difficile infection. Secondarily investigators will also see if there is any impact of BSS in
 decrease the recurrence.
Clostridium difficile (C.Diff) infection is the leading cause of hospital acquired infection
 and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is
 the challenging task for clinicians due to treatment resistance developed from new
 hypervirulent strains. The recurrence rate of this infection is around 20% and there is high
 likelihood (60-70%) of another episode after index recurrence. Given constant challenges new
 treatment options are under study.

 The purpose of this study is to examine if the addition of bismuth subsalicylate (BSS) (the
 active ingredient in Pepto-Bismol) 524 mg ((2) 262 mg tablets) given four times per day for
 14 days to standard of care treatment of C.Diff will decrease the length of stay and decrease
 the time to resolution of C.Diff symptoms compared to patients who received standard of care
 treatment for C.Diff alone.

 Bismuth subsalicylate has been used for long time in infectious diarrhea and is over the
 counter drug with few side effects. Studies in hamsters have shown bismuth subsalicylate to
 be effective in treating C.Diff. Investigators believe given cheaper cost and less side
 effect profile this drug is worth looking for treatment of C.Diff infection which has a huge
 burden on health care.

 This is an open label, randomized, controlled trial. Hospitalized patients aged 18 years or
 older with positive stool test for C.Diff toxin will be randomized to one of two treatment
 groups:

 Group 1 will receive standard of care treatment for C.Diff alone Group 2 will receive BSS 524
 mg four times daily for 14 days along with standard of care treatment Oral antibiotic therapy
 will be limited to oral vancomycin 125 mg every 6 hours daily which is the standard dose for
 the treatment of clostridium difficile.

 Length of stay and time to resolution of symptoms will be measured and compared between the
 two treatment groups as primary outcomes. Resolution of symptoms is defined has having < 3
 diarrheal episodes in 24 hours. The study will also record episodes of recurrence, defined as
 the reappearance of symptoms within 8 weeks of the completion of antibiotic treatment and the
 resolution of initial symptoms. Recurrence rates will be compared between the two treatment
 groups as a secondary outcome.

 Both Groups 1 & 2 will have 2 week and 8 week follow up phone calls. Group 1 participants
 will be called 2 weeks after consent/enrollment in the study to verify antibiotic therapy is
 completed, verify when/if CDiff symptoms resolved, collect data about any adverse events.
 Group 2 participants will be called 2 weeks after the initiation of study drug (which should
 be < 24 hours after consent). The visit window will start on the day the participant is
 scheduled to complete study drug. The purpose of the call will be to verify that both
 antibiotics and study drug have been completed, verify when/if CDiff symptoms resolved, and
 collect data about any adverse events.

 Both Groups 1 and 2 participants will be called 8 weeks after the expected (or known)
 completion date of antibiotic therapy prescribed for the treatment of CDiff to see if CDiff
 symptoms have recurred and if there have been any adverse events..
Inclusion Criteria:

 -  Age 18 or older

 -  Hospitalized patient with documented positive stool test for CDiff

 -  Able and willing to provide informed consent

 Exclusion Criteria:

 -  Pregnancy

 -  Breastfeeding

 -  Known allergy to BSS or other salicylates, including aspirin

 -  History of bleeding disorder

 -  History of gastrointestinal bleed,

 -  History of gastrointestinal ulcer

 -  Chronic use of anticoagulants

 -  Chronic NSAID use