Irritable Bowel SyndromeNCT01436760
Genetic Contribution of Pain and Inflammation in IBS
An observational study of Irritable Bowel Syndrome, run by University of Florida at 1 site in United States.
Trial summary
The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Generic laboratory blood bank
Who may be able to join
- Subjects with IBS and previously stored samples
Who cannot join
- Subjects without IBS and no previously stored samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Contribution of Pain and Inflammation in Irritable Bowel Syndrome.
The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.
Read the detailed description
Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphisms
The goal of the study isd to identify possible polymorphisms on the loci of canidate genes that may be involved in modulation of pain and inflammation in irritable Bowel Syndrome.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baharak Moshiree, MD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436760
- Sponsor's protocol ID
- 132-2011
- Status last verified
- Mar 2012
- First submitted
- 16 Sep 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Contribution of Pain and Inflammation in Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT01436760
- Acronym / sponsor ID
- 132-2011
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Sep 2011 (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 goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.
Detailed description
Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Generic laboratory blood bank
Key inclusion criteria (1 listed)
- Subjects with IBS and previously stored samples
Key exclusion criteria (1 listed)
- Subjects without IBS and no previously stored samples
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
Polymorphisms
Time frame: one year
The goal of the study isd to identify possible polymorphisms on the loci of canidate genes that may be involved in modulation of pain and inflammation in irritable Bowel Syndrome.
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 26 Mar 2012.
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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.
Baharak Moshiree, MD, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University of Florida at 1 site 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 1 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 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Polymorphisms (time frame: one 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 26 Mar 2012.