ColitisNCT02768038
Intestinal Microbiome and Chronic Inflammatory Bowel Disease
An observational study of Colitis, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis
- What is being tested?
- Observational
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2016to 1 Dec 2020
- How long will I take part?
- 5 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IBD living at the Turku University Hospital area
Who may be able to join
- IBD
Who cannot join
- patient refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Intestinal Microbiome ih the Pathogenesis and Course of Chronic Inflammatory Bowel Diseases
The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)
Read the detailed description
IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.
- Conditions
- Colitis
- Being tested
- Observational
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Blood, stool ja biopsy specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of microbiome in chronic inflammatory bowel disease
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 May 2016 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: The researcher (Ph student) interrupted the dissertation project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Markku Voutilainen, Prof., Principal investigator, Head, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768038
- Sponsor's protocol ID
- TurkuUH2
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2015
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intestinal Microbiome ih the Pathogenesis and Course of Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT02768038
- Acronym / sponsor ID
- TurkuUH2
- Conditions
- Colitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The researcher (Ph student) interrupted the dissertation project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 May 2016 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 May 2016 (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 aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)
Detailed description
IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IBD living at the Turku University Hospital area
Key inclusion criteria (1 listed)
- IBD
Key exclusion criteria (1 listed)
- patient refusal to participate
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 |
|---|---|---|
| ObservationalBlood, stool ja biopsy specimens | Other | – |
Primary outcome
Change of microbiome in chronic inflammatory bowel disease
Time frame: 5 yrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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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.
Markku Voutilainen, Prof. principal investigator
Head, Department of Gastroenterology
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 Colitis, run by Turku University Hospital at 1 site in Finland.
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: withdrawn, as of the sponsor's last update on 1 May 2025. 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 Finland. 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 withdrawn before enrolling participants, so there are no results.
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?
Change of microbiome in chronic inflammatory bowel disease (time frame: 5 yrs). 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 1 May 2025.