Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
| Status: | Suspended |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2016 |
| Start Date: | October 2007 |
Study of the Efficacy of Loperamide in Treating Patients for Clostridium Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Prior Antibiotic Therapy.
To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and
mortality of this serious nosocomial infection in patients who have antibiotic-associated
diarrhea. Both C. diff positive and negative patients will be included.
mortality of this serious nosocomial infection in patients who have antibiotic-associated
diarrhea. Both C. diff positive and negative patients will be included.
Colitis due to Clostridium difficile has been increasingly recognized as a serious
nosocomial problem. Recommended therapy is with metronidazole, 500 mg four times daily for
10 days. About 80% of patients respond to this therapy. However, the response may be be
delayed, in which case debilitation due to diarrhea progresses. The 20% who do not respond
tend to be sicker to start, and debilitation due to diarrhea is a severe problem. In
reviewing the medical literature, we discovered that the earliest papers on C. difficile
colitis emphasized symptomatic therapy with 'lomotil' (diphenoxylate with atropine).
Treatment to suppress the diarrhea fell out of favor in the late 1970's because of the
theoretical consideration that it was better to expel than to retain the bacterial toxins.
However, the patients who are affected by C. difficile colitis are increasingly elderly and
debilitated, and suffer substantial morbidity from the diarrhea. We have shown that the
90-day associated mortality is >20%.
Loperamide is a standard treatment for diarrhea, and is available over the counter under the
name, Imodium. Based on a few anecdotal reports, this drug is regarded as contraindicated in
patients whose diarrheal disease is bacterial. But it is used widely, and generally without
any diagnosis being established. We now propose to administer loperamide or placebo to
patients with CDAD in order to determine whether the antidiarrheal drug reduces morbidity
associated with the infection. We will monitor our patients closely both to observe
potential benefits and/or adverse events.
In the addendum, we propose to include patients who have antibiotic-associated diarrheal
disease that is not due to C. difficile. There are many patients who have
antibiotic-associated diarrheal disease who test negative for C. difficile. We believe that
these patient may benefit from loperamide treatment as well.
nosocomial problem. Recommended therapy is with metronidazole, 500 mg four times daily for
10 days. About 80% of patients respond to this therapy. However, the response may be be
delayed, in which case debilitation due to diarrhea progresses. The 20% who do not respond
tend to be sicker to start, and debilitation due to diarrhea is a severe problem. In
reviewing the medical literature, we discovered that the earliest papers on C. difficile
colitis emphasized symptomatic therapy with 'lomotil' (diphenoxylate with atropine).
Treatment to suppress the diarrhea fell out of favor in the late 1970's because of the
theoretical consideration that it was better to expel than to retain the bacterial toxins.
However, the patients who are affected by C. difficile colitis are increasingly elderly and
debilitated, and suffer substantial morbidity from the diarrhea. We have shown that the
90-day associated mortality is >20%.
Loperamide is a standard treatment for diarrhea, and is available over the counter under the
name, Imodium. Based on a few anecdotal reports, this drug is regarded as contraindicated in
patients whose diarrheal disease is bacterial. But it is used widely, and generally without
any diagnosis being established. We now propose to administer loperamide or placebo to
patients with CDAD in order to determine whether the antidiarrheal drug reduces morbidity
associated with the infection. We will monitor our patients closely both to observe
potential benefits and/or adverse events.
In the addendum, we propose to include patients who have antibiotic-associated diarrheal
disease that is not due to C. difficile. There are many patients who have
antibiotic-associated diarrheal disease who test negative for C. difficile. We believe that
these patient may benefit from loperamide treatment as well.
Inclusion Criteria:
- Patients with diarrheal stools considered to be antibiotic associated
Exclusion Criteria:
- Inability of sign consent
- Patient with other known gastrointestinal disease
- Patients receiving tube feeding or fecal incontinence prior to receiving antibiotics
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