Ulcerative ColitisNCT01961492
Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
A study testing Fecal microbiota transplantation in people with Ulcerative Colitis, run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2013to Dec 2018
- 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 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed
Who cannot join
- severe ulcerative colitis (PUCAI > 65)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis
The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal microbiota transplantation
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
A single fecal microbiota transplantation through colonoscope
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Active comparator | A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment Receives: Other: Fecal microbiota transplantation |
| Standard medical treatment | No intervention | Standard medical treatment as recommended by the ECCO Guidelines of UC therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of ulcerative colitis
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
Measured: Within 1 year after the intervention
Secondary outcomes (3)
Colonic inflammation
Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
Measured: Within 1 year after the intervention
Colonic inflammation
Endoscopic Mayo score at 3 and 12 months after the intervention
Measured: Within 1 year after the intervention
Adverse events
Measured: Within 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Problems in recruiting
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 Turku University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marko Kalliomäki, Turku University Hospital
- Investigators
- Marko Kalliomäki, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961492
- Sponsor's protocol ID
- 15881
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2013
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01961492
- Acronym / sponsor ID
- 15881
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems in recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Oct 2013 (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 find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Active comparator | Other: Fecal microbiota transplantationA single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment |
| Standard medical treatment | No intervention | –Standard medical treatment as recommended by the ECCO Guidelines of UC therapy. |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed
Key exclusion criteria (1 listed)
- severe ulcerative colitis (PUCAI > 65)
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 |
|---|---|---|
| Fecal microbiota transplantationA single fecal microbiota transplantation through colonoscope | Other | Fecal microbiota transplantation |
Primary outcome
Activity of ulcerative colitis
Time frame: Within 1 year after the intervention
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
3 secondary outcomes
Colonic inflammation
Time frame: Within 1 year after the intervention
Colonic inflammation
Time frame: Within 1 year after the intervention
Adverse events
Time frame: Within 1 year after the intervention
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 17 Oct 2018.
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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.
Marko Kalliomäki, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Ulcerative 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 17 Oct 2018. 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?
Activity of ulcerative colitis (time frame: Within 1 year after the intervention). 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 17 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.