Ulcerative ColitisPhase 2NCT01545908
Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis
A Phase 2 study testing Fecal transplant in people with Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. 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?
- Fecal transplant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Aug 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
- Patients aged 18 or over with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study
- Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more than or equal to 12 weeks prior to randomization.
Who cannot join
- Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, L8N 3Z5
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis
Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.
Read the detailed description
Hypothesis Fecal biotherapy will be more effective than placebo at inducing remission in patients with active UC.
Approach and work plan Patients aged 18 or over with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study. Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more or equal to 12 weeks prior to randomization. Eligible patients will be randomized to receive fecal biotherapy or placebo. Fecal biotherapy will be provided by an unrelated donor who is able to give informed consent, travel to the treatment centre at St Joseph's Hospital, Hamilton and able to collect fecal sample as needed for the fecal transplantation protocol. Fecal microbiome profiling will be carried out using both Roche 454 pyrosequencing and Illumina sequencing.
One hundred and thirty active UC patients will be randomized 1:1 according to a computer generated randomization list. Randomization will be administered centrally at the GI Clinical Trials Unit to ensure concealment of allocation. Eligible patients will be randomized to receive a weekly fecal biotherapy enema or a placebo enema for six weeks. In order to mitigate a placebo effect, both the patient and study staff will be blinded to the allocation of the treatment. An unblinded, independent laboratory technologist will prepare the retention enema according to the treatment arm to which the patient is assigned. The enema containers will be fully colour-tinted from the tip to the bottom of the container. The container will be placed inside a paper bag, which contains baking soda to absorb the odor. Both the patient and the study nurse will be required to wear a tightly fitted mask at all times during the infusion and retention of the enema.
Subjects will have a sigmoidoscopy (or colonoscopy if clinically indicated), physician assessment and complete a Mayo score (13) and IBDQ questionnaire (15) at baseline. The physician assessment, IBDQ and partial Mayo score (Mayo score without the sigmoidoscopy) will be repeated at 3 weeks. A repeat sigmoidoscopy, physician assessment IBDQ and Mayo score will be completed at 6 weeks, at exit from the study. No new medical therapies (e.g. corticosteroids, antibiotics, probiotics) will be permitted during the six-week study period. At the end of the treatment component of the study, fecal biotherapy will be offered to the participants in the placebo arm with clinical and sigmoidoscopic evidence of active UC.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal transplant, Placebo enema
- Keywords
- Fecal transplant, induction of remission, active 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.
Fecal transplantOther
Also called Fecal bacteriotherapy, fecal biotherapy.
Participants in this arm undergo 6 retention enemas,using stool specimen prepared from a healthy, screened unrelated donor.
Placebo enemaOther
Also called saline enema
Patients will receive placebo enema, week 1, week 2, week 3, week 4, week 5, week 6
| Study group | Role | What they receive |
|---|---|---|
| placebo enema | Placebo comparator | Participants in this arm undergo 6 retention enemas, week 1, week 2, week 3, week 4, week 5, week 6 Receives: Other: Placebo enema |
| Fecal transplant from an unrelated donor | Active comparator | Participants in this arm undergo 6 retention enemas,week 1, week 2, week 3, week 4, week 5, week 6,using stool specimen prepared from a healthy, screened donor. Receives: Other: Fecal transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks
All analyses will be conducted using both intention-to-treat and per-protocol, and the differences in remission rates and relapse rates between the two groups will be statistically analysed. The usual descriptive statistics using Fisher exact test, proportion test, rank test and t-test will be used to compare the two populations making sure that the randomization split the sample into two homogenous sub-samples. Logistic regression and estimating equations will also be used.
Measured: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.
Secondary outcomes (1)
Secondary outcomes include endoscopic and clinical remission defined as a Mayo score = 0 and improvement in symptoms defined as a decrease ≥3 in the Mayo score from baseline at 6 weeks.
All analyses will be conducted using both intention-to-treat and per-protocol, and the differences in remission rates and relapse rates between the two groups will be statistically analysed. The usual descriptive statistics using Fisher exact test, proportion test, rank test and t-test will be used to compare the two populations making sure that the randomization split the sample into two homogenous sub-samples. Logistic regression and estimating equations will also be used.
Measured: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Moayyedi, Hamilton Health Sciences Corporation
- Investigators
- Christine Lee, MD, Principal investigator, St. Joseph's Hamilton HealthcarePaul Moayyedi, MD, FRCP, Principal investigator, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545908
- Sponsor's protocol ID
- REB # 11-600
- Status last verified
- Mar 2015
- First submitted
- 22 Feb 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.
PubMed 21871249Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
PubMed 25857665
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01545908
- Acronym / sponsor ID
- REB # 11-600
- Conditions
- Ulcerative Colitis
- Keywords
- Fecal transplant, induction of remission, active ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Mar 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 is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.
Detailed description
Hypothesis Fecal biotherapy will be more effective than placebo at inducing remission in patients with active UC.
Approach and work plan Patients aged 18 or over with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study. Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more or equal to 12 weeks prior to randomization. Eligible patients will be randomized to receive fecal biotherapy or placebo. Fecal biotherapy will be provided by an unrelated donor who is able to give informed consent, travel to the treatment centre at St Joseph's Hospital, Hamilton and able to collect fecal sample as needed for the fecal transplantation protocol. Fecal microbiome profiling will be carried out using both Roche 454 pyrosequencing and Illumina sequencing.
One hundred and thirty active UC patients will be randomized 1:1 according to a computer generated randomization list. Randomization will be administered centrally at the GI Clinical Trials Unit to ensure concealment of allocation. Eligible patients will be randomized to receive a weekly fecal biotherapy enema or a placebo enema for six weeks. In order to mitigate a placebo effect, both the patient and study staff will be blinded to the allocation of the treatment. An unblinded, independent laboratory technologist will prepare the retention enema according to the treatment arm to which the patient is assigned. The enema containers will be fully colour-tinted from the tip to the bottom of the container. The container will be placed inside a paper bag, which contains baking soda to absorb the odor. Both the patient and the study nurse will be required to wear a tightly fitted mask at all times during the infusion and retention of the enema.
Subjects will have a sigmoidoscopy (or colonoscopy if clinically indicated), physician assessment and complete a Mayo score (13) and IBDQ questionnaire (15) at baseline. The physician assessment, IBDQ and partial Mayo score (Mayo score without the sigmoidoscopy) will be repeated at 3 weeks. A repeat sigmoidoscopy, physician assessment IBDQ and Mayo score will be completed at 6 weeks, at exit from the study. No new medical therapies (e.g. corticosteroids, antibiotics, probiotics) will be permitted during the six-week study period. At the end of the treatment component of the study, fecal biotherapy will be offered to the participants in the placebo arm with clinical and sigmoidoscopic evidence of active UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo enema | Placebo comparator | Other: Placebo enemaParticipants in this arm undergo 6 retention enemas, week 1, week 2, week 3, week 4, week 5, week 6 |
| Fecal transplant from an unrelated donor | Active comparator | Other: Fecal transplantParticipants in this arm undergo 6 retention enemas,week 1, week 2, week 3, week 4, week 5, week 6,using stool specimen prepared from a healthy, screened donor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 or over with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study
- Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more than or equal to 12 weeks prior to randomization.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization.
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 transplantAlso: Fecal bacteriotherapy, fecal biotherapy.Participants in this arm undergo 6 retention enemas,using stool specimen prepared from a healthy, screened unrelated donor. | Other | Fecal transplant from an unrelated donor |
| Placebo enemaAlso: saline enemaPatients will receive placebo enema, week 1, week 2, week 3, week 4, week 5, week 6 | Other | placebo enema |
Primary outcome
The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks
Time frame: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.
All analyses will be conducted using both intention-to-treat and per-protocol, and the differences in remission rates and relapse rates between the two groups will be statistically analysed. The usual descriptive statistics using Fisher exact test, proportion test, rank test and t-test will be used to compare the two populations making sure that the randomization split the sample into two homogenous sub-samples. Logistic regression and estimating equations will also be used.
1 secondary outcome
Secondary outcomes include endoscopic and clinical remission defined as a Mayo score = 0 and improvement in symptoms defined as a decrease ≥3 in the Mayo score from baseline at 6 weeks.
Time frame: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.
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 19 Mar 2015.
- Results publication: PubMed 21871249Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.
- Derived from this study: PubMed 25857665Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
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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.
Christine Lee, MD principal investigator
St. Joseph's Hamilton Healthcare
Paul Moayyedi, MD, FRCP principal investigator
Hamilton Health Sciences, McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal transplant in people with Ulcerative Colitis, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
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 2 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: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (time frame: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.). 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 NCT01545908, which also lists 2 linked publications.
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 19 Mar 2015.