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CompletedNCT00304876Updated Sep 10, 2010

Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

An observational study in Enterocolitis, Pseudomembranous Colitis and Antibiotic-Associated Colitis, sponsored by Michael E. DeBakey VA Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-10.

Primary conditionEnterocolitis, PseudomembranousRegistry: EnterocolitisReclassifiedWhy we changed it
Registry
Enterocolitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Enterocolitis, Pseudomembranous
Why
  1. The study's listed conditions name Enterocolitis, Pseudomembranous, a narrower term within Enterocolitis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Michael E. DeBakey VA Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study summary

The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Read the detailed description

Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

02

Conditions studied

  • Enterocolitis
  • Pseudomembranous Colitis
  • Antibiotic-Associated Colitis

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Keywords

  • Clostridium difficile associated diarrhea
03

In context

Enterocolitis, Pseudomembranous Reclassified

43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.

Browse Enterocolitis, Pseudomembranous studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 27 studies on the registry; none are open to participants now.

Compared within Enterocolitis, Pseudomembranous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Enterocolitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients positive for C. difficile

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
  • Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
  • Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
  • Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5 participants (actual)
06

Study locations

2 sites
  • Johns Hopkins Medical Research Institute
    Baltimore, Maryland 21205, United States
  • Michael E. DeBakey Veterans Affairs Medical Center
    Houston, Texas 77030, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2005, a primary completion of Jan 2007 and a completion of Jan 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2006
First posted
Mar 20, 2006
Start
Oct 2005
Primary completionActual
Jan 2007
CompletionActual
Jan 2007
Last update
Sep 10, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00304876
Lead sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Baylor College of Medicine
First posted
Mar 20, 2006
Start date
Oct 2005
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Sep 10, 2010

Study contacts

Daniel M Musher, M.D.
principal investigator · Baylor College of Medicine, Houston VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Michael E. DeBakey VA Medical Center

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