EnterocolitisNCT00304876
Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
An observational study of Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients positive for C. difficile
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Medical Research Institute
Baltimore, Maryland, 21205
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
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.
- Keywords
- Clostridium difficile associated diarrhea
- Medical subject headings
- Enterocolitis, Enterocolitis, Pseudomembranous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Investigators
- Daniel M Musher, M.D., Principal investigator, Baylor College of Medicine, Houston VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304876
- Sponsor's protocol ID
- H-18158
- Status last verified
- Sep 2010
- First submitted
- 16 Mar 2006
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
- ClinicalTrials.gov ID
- NCT00304876
- Acronym / sponsor ID
- H-18158
- Keywords
- Clostridium difficile associated diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients positive for C. difficile
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M Musher, M.D. principal investigator
Baylor College of Medicine, Houston VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2010.