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Study Title and Description

Randomized controlled trial of colestipol in antibiotic-associated colitis.



Key Questions Addressed
7 Key Question 7 - Nonstandard intervention for treatment of initial and recurrent CDI
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Primary Publication Information
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TitleData
Title Randomized controlled trial of colestipol in antibiotic-associated colitis.
Author Mogg GA., George RH., Youngs D., Johnson M., Thompson H., Burdon DW., Keighley MR.
Country -- Not Found --
Year 1982
Numbers Pubmed ID: 7039758
1410 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 4 - Nonstandard intervention for treatment of initial and recurrent CDI (Tables 19, C9)
Design Details
Question... Follow Up Answer Follow-up Answer
Comparison Nonstandard Intervention Versus Placebo
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Sample 48 patients on a single surgical unit with severe diarrhea after antibiotic treatment 48 entered study and 10 withdrew (7 on resin and 3 on placebo), 38 analyzed (79%) No information on age and gender. Diarrhea defined as •3 loose stools/day or more than 1 L of drainage from colostomy Previous placebo group (n=22) from prior study of vancomycin and placebo on same unit.
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Intervention/ Comparison and Method Absorptive resin Colestipol 10 g every day mixed in fruit squash x 5 days (n=17) Placebo (sherbet) (n=21) Stool tested for Clostridium difficile cytotoxin at study start, on day 3 and last day of treatment (day 5) Outcome was defined as return of diarrheal stool to normal, (i.e., 2 solid stools in 24 hours) in stools that were positive for C. difficile OR its toxin
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Resolution of Clostridium difficile infection (Diarrhea and Clostridium difficile Toxin Positive Stool) Colestipol: 3/12 (25%) Placebo: 3/14 (21%)
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Other Outcomes
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Study Quality Allocation concealment: Possibly adequate ("identical placebo") Blinding: not reported Intention-to-treat analysis: no Withdrawals and dropouts adequately described: yes Notes: Clostridium difficile cytotoxin was not present in all subjects reported as cases No statistical testing Some historical controls included with concurrent controls Clostridium difficile treatment and prevention findings were combined (i.e., findings of subjects with C. difficile or its toxin in stool before receiving the intervention were combined with those who acquired these during the intervention)
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Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Allocation Concealment Possibly adequate
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Blinding None stated
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Intention-to-Treat Analysis No
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Withdrawals and Dropouts Adequately Described Yes
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Study Quality Fair
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Quality Rating
No quality rating data was found.