Ulcerative ColitisPhase 2TURNNCT01650038
Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis
A Phase 2 study testing treatment with faecal transplantation (donor faeces) and treatment with faecal transplantation (own faeces) in people with Ulcerative Colitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- treatment with faecal transplantation (donor faeces) and treatment with faecal transplantation (own faeces)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Ability to give informed consent
- Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
- SCCAI of 4 > < 11
- Endoscopic Mayo score of > 1
- Stable dose of thiopurines in preceding 8 weeks
- Stable dose of corticosteroids and 5-ASA in preceding 2 weeks
Who cannot join
- Condition leading to profound immunosuppression
- Anti-TNF treatment in preceding 2 months
- Cyclosporine treatment in preceding 4 weeks
- Use of Methotrexate in preceding 2 months
- Prednisolone dose > 10 mg
- Life expectancy < 12 months
Show all 12Show fewer
- Use of systemic antibiotics in preceding 6 weeks
- Use of probiotic treatment in preceding 6 weeks
- Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
- Positive faecal PCR-test (positive PCR means: > 1 of the following viruses is present) for: Rotavirus, Norovirus, Enterovirus, Parechovirus Sapovirus, Adenovirus 40/41/52. Astrovirus.
- Pregnancy or women who give breastfeeding
- Vasopressive medication, icu stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.
Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.
Read the detailed description
treatment with faecal transplantation from a healthy donor in active ulcerative colitis patients. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.
- Conditions
- Ulcerative Colitis
- Being tested
- treatment with faecal transplantation (donor faeces), treatment with faecal transplantation (own faeces)
- Keywords
- faecal transplantation, ulcerative colitis, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with faecal transplantation (donor faeces)Other
faecal transplantation
treatment with faecal transplantation (own faeces)Other
faecal transplantation
| Study group | Role | What they receive |
|---|---|---|
| faecal transplantation; donor faeces | Active comparator | 2 times treatment with faecal transplantation: faeces from a healthy donor processed for duodenal tube infusion. after bowel lavage with macrogol. Receives: Other: treatment with faecal transplantation (donor faeces) |
| faecal transplantation; placebo | Placebo comparator | 2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol. Receives: Other: treatment with faecal transplantation (own faeces) |
What is being measured
The primary outcome is the main question the study is designed to answer.
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score
- clinical remission = questionnaire: SCCAI 2 or lower
- reduction of Mayo endoscopic inflammation score= decrement of 1 or more as assessed by sigmoidoscopy
Measured: at 12 weeks after treatment.
Secondary outcomes (3)
Simple clinical colitis activity index (SCCAI) score reduction
Measured: time: 6 weeks after treatment
Frequency of bowel movements
Measured: start at baseline up to 6 weeks after treatment
Time to recurrence
Measured: from timepoint 12 weeks after treatment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- C Ponsioen, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650038
- Sponsor's protocol ID
- METC 2011_005
- Acronym
- TURN
- Status last verified
- Dec 2014
- First submitted
- 18 Jul 2012
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
PubMed 25836986
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
- ClinicalTrials.gov ID
- NCT01650038
- Acronym / sponsor ID
- TURN / METC 2011_005
- Conditions
- Ulcerative Colitis
- Keywords
- faecal transplantation, ulcerative colitis, inflammatory bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jul 2012 (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.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.
Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.
Detailed description
treatment with faecal transplantation from a healthy donor in active ulcerative colitis patients. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| faecal transplantation; donor faeces | Active comparator | Other: treatment with faecal transplantation (donor faeces)2 times treatment with faecal transplantation: faeces from a healthy donor processed for duodenal tube infusion. after bowel lavage with macrogol. |
| faecal transplantation; placebo | Placebo comparator | Other: treatment with faecal transplantation (own faeces)2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- Ability to give informed consent
- Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
- SCCAI of 4 > < 11
- Endoscopic Mayo score of > 1
Key exclusion criteria (12 listed)
- Condition leading to profound immunosuppression
- Anti-TNF treatment in preceding 2 months
- Cyclosporine treatment in preceding 4 weeks
- Use of Methotrexate in preceding 2 months
- Prednisolone dose > 10 mg
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 |
|---|---|---|
| treatment with faecal transplantation (donor faeces)faecal transplantation | Other | faecal transplantation; donor faeces |
| treatment with faecal transplantation (own faeces)faecal transplantation | Other | faecal transplantation; placebo |
Primary outcome
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score
Time frame: at 12 weeks after treatment.
* clinical remission = questionnaire: SCCAI 2 or lower * reduction of Mayo endoscopic inflammation score= decrement of 1 or more as assessed by sigmoidoscopy
3 secondary outcomes
Simple clinical colitis activity index (SCCAI) score reduction
Time frame: time: 6 weeks after treatment
Frequency of bowel movements
Time frame: start at baseline up to 6 weeks after treatment
Time to recurrence
Time frame: from timepoint 12 weeks after treatment up to 12 months
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 30 Dec 2014.
- Derived from this study: PubMed 25836986Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
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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.
C Ponsioen, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treatment with faecal transplantation (donor faeces) and treatment with faecal transplantation (own faeces) in people with Ulcerative Colitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 7 inclusion and 12 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 30 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (time frame: at 12 weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650038, which also lists 1 linked publication.
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 30 Dec 2014.