Molecular AnalysisNCT00882752
Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy Sample
An observational study of Molecular Analysis, run by Southwest Regional Wound Care Center.
Trial summary
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Molecular Analysis
- What is being tested?
- molecular analysis
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Nov 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: People with ulcerative colitis.
Who may be able to join
- Diagnosis of ulcerative colitis
- Age >= 18 years old
- Female
Who cannot join
- Anyone not meeting inclusion criteria.
About this study
Official title: Retrospective Study Protocol: Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians.
Read the detailed description
The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. The molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.
- Conditions
- Molecular Analysis
- Being tested
- molecular analysis
- Keywords
- Ulcerative Colitis (UC)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular analysisProcedure or surgery
bowel disease
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitius | The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. Receives: Procedure: molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular AnalysisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall Wolcott, MD, Principal investigator, Southwest Regional Wound CareRandall Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882752
- Sponsor's protocol ID
- 56-RW-009
- Status last verified
- Sep 2011
- First submitted
- 29 Sep 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Protocol: Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy
- ClinicalTrials.gov ID
- NCT00882752
- Acronym / sponsor ID
- 56-RW-009
- Conditions
- Molecular Analysis
- Keywords
- Ulcerative Colitis (UC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Apr 2009 (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 method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians.
Detailed description
The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. The molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitius | – | Procedure: molecular analysisThe method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with ulcerative colitis.
Key inclusion criteria (3 listed)
- Diagnosis of ulcerative colitis
- Age >= 18 years old
- Female
Key exclusion criteria (1 listed)
- Anyone not meeting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular analysisbowel disease | Procedure or surgery | Ulcerative colitius |
Primary outcome
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections.
Time frame: 1 year
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 7 Sep 2011.
Related trials for Molecular Analysis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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.
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care Center
Questions about this trial
What is this clinical trial studying?
An observational study of Molecular Analysis, run by Southwest Regional Wound Care Center.
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 3 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 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 7 Sep 2011.