Crohn's DiseaseNCT01012726
Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
A study testing Colonoscopy in people with Crohn's Disease, run by Gerhard Rogler at 1 site in Switzerland.
Trial summary
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Jul 2012
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fistulizing CD
- CD < 6 months
- at least one insufficient fistula closure try
Who cannot join
- CDAI > 200
- Abscesses
- CRP > 100
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.
- Conditions
- Crohn's Disease
- Being tested
- Colonoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula closure
Measured: 01.08.2009 - 31.07.2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2012
Why it stopped: not enough patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerhard Rogler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerhard Rogler, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012726
- Sponsor's protocol ID
- FIST-MC-09
- Status last verified
- Dec 2014
- First submitted
- 11 Nov 2009
- Last updated
- 4 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
- ClinicalTrials.gov ID
- NCT01012726
- Acronym / sponsor ID
- FIST-MC-09
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients enrolled
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gerhard RoglerUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Nov 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 investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fistulizing CD
- CD < 6 months
- at least one insufficient fistula closure try
Key exclusion criteria (3 listed)
- CDAI > 200
- Abscesses
- CRP > 100
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 |
|---|---|---|
| ColonoscopyDuring the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula. | Procedure or surgery | – |
Primary outcome
Fistula closure
Time frame: 01.08.2009 - 31.07.2012
Results and safety
The study was stopped early (reason given: not enough patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Crohn's Disease, run by Gerhard Rogler at 1 site in Switzerland.
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 3 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: stopped early, as of the sponsor's last update on 4 Dec 2014. 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 Switzerland. 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 was stopped early (reason given: not enough patients enrolled). Results are not available in the source record.
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?
Fistula closure (time frame: 01.08.2009 - 31.07.2012). 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 4 Dec 2014.