Ulcerative ColitisNCT01282905
Hydrogen Sulfide Detoxification and Butyrate Metabolism in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 106 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Dec 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: IBD patients clinic (Universitaire Ziekenhuizen Leuven)
Who may be able to join
- Ulcerative colitis patients: patients diagnosed with ulcerative colitis
Who cannot join
- Healthy controls: no diagnosis of inflammatory bowel diseases
- Intake of antibiotics in the last month before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Mucosal Detoxification Mechanism of Hydrogen Sulphide on the Oxidation Pathway of Butyrate in Ulcerative Colitis
The purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls.
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described | |
| Ulcerative colitis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startOct 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Kristin Verbeke, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282905
- Sponsor's protocol ID
- ML3999
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Mucosal Detoxification Mechanism of Hydrogen Sulphide on the Oxidation Pathway of Butyrate in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01282905
- Acronym / sponsor ID
- ML3999
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2008
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jan 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 purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | – |
| Ulcerative colitis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients clinic (Universitaire Ziekenhuizen Leuven)
Key inclusion criteria (1 listed)
- Ulcerative colitis patients: patients diagnosed with ulcerative colitis
Key exclusion criteria (2 listed)
- Healthy controls: no diagnosis of inflammatory bowel diseases
- Intake of antibiotics in the last month before the study
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 26 Jan 2011.
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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.
Kristin Verbeke, PhD principal investigator
KU Leuven
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 Ulcerative Colitis, run by KU Leuven at 1 site in Belgium.
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 2 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 Jan 2011. 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 Belgium. 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 26 Jan 2011.