Ulcerative ColitisPhase 2FOCUSNCT01896635
Faecal Microbiota Transplantation in Ulcerative Colitis
A Phase 2 study testing FMT infusions in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by The University of New South Wales at 3 sites in Australia.
Trial summary
The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- FMT infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 3 sitesAustralia
- Study dates
- Nov 2013to Aug 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative colitis >3 months duration
- Active mild-moderate ulcerative colitis (Mayo 4-10)
- Ulcerative colitis of any extent except isolated proctitis < 5cm
- Live within driving distance of clinical site (to attend multiple study visits)
Who cannot join
- Pregnancy
- Active gastrointestinal infection
- Other gastrointestinal disease / comorbidities
- Prior colonic surgery
- Recent antibiotic or probiotic use
- Prednisone > 20mg
- Monoclonal antibody immunosuppressive therapy
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Nambour General Hospital
Nambour, Queensland, 4560
St Vincent's Hospital
Sydney, New South Wales, 2010
Bankstown-Lidcombe Hospital
Sydney, New South Wales, 2200
About this study
Official title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial
Read the detailed description
This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Being tested
- FMT infusions, Placebo infusion
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation
- 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.
FMT infusionsBiological
Active FMT derived from healthy anonymous pre-screened donors
Placebo infusionOther
Placebo infusion not containing any donor microbial material
| Study group | Role | What they receive |
|---|---|---|
| FMT infusions | Active comparator | FMT infusions constituted from stool provided by healthy, screened donors Receives: Biological: FMT infusions |
| Placebo arm | Placebo comparator | Placebo infusions Receives: Other: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Measured: 8 weeks
Secondary outcomes (6)
Clinical remission as measured by Mayo subscores
Measured: 8 weeks
Clinical response as measured by Mayo subscores
Measured: 8 weeks
Endoscopic healing as measured by UCEIS
Measured: 8 weeks
Treatment failure rate as defined by Mayo subscores
Measured: 8 weeks
Quality of life as measured by IBDQ
Measured: 8 weeks
Safety and tolerability as measured by adverse event data
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sudarshan Paramsothy, The University of New South Wales
- Investigators
- Hazel Mitchell, BSc PhD, Principal investigator, University of New South WalesAlissa Walsh, MBBS, Principal investigator, St Vincent's Hospital, SydneyJohan van den Bogaerde, MBChB PhD, Principal investigator, Nambour General Hospital, QueenslandDouglas Samuel, MBBS MMed, Principal investigator, Bankstown-Lidcombe Hospital, SydneyNadeem O Kaakoush, BSc PhD, Principal investigator, University of New South WalesMichael Kamm, MBBS MD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896635
- Sponsor's protocol ID
- FOCUS
- Acronym
- FOCUS
- Status last verified
- Oct 2016
- First submitted
- 6 Jul 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
Publications
Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO. Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Gastroenterology. 2019 Apr;156(5):1440-1454.e2. doi: 10.1053/j.gastro.2018.12.001. Epub 2018 Dec 6.
PubMed 30529583Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
PubMed 28214091Paramsothy S, Walsh AJ, Borody T, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush NO, Kamm MA. Gastroenterologist perceptions of faecal microbiota transplantation. World J Gastroenterol. 2015 Oct 14;21(38):10907-14. doi: 10.3748/wjg.v21.i38.10907.
PubMed 26478682Paramsothy S, Borody TJ, Lin E, Finlayson S, Walsh AJ, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush N, Kamm MA. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis. 2015 Jul;21(7):1600-6. doi: 10.1097/MIB.0000000000000405.
PubMed 26070003
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
- ClinicalTrials.gov ID
- NCT01896635
- Acronym / sponsor ID
- FOCUS / FOCUS
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Jul 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 determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial
Detailed description
This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy
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 |
|---|---|---|
| FMT infusions | Active comparator | Biological: FMT infusionsFMT infusions constituted from stool provided by healthy, screened donors |
| Placebo arm | Placebo comparator | Other: Placebo infusionPlacebo infusions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ulcerative colitis >3 months duration
- Active mild-moderate ulcerative colitis (Mayo 4-10)
- Ulcerative colitis of any extent except isolated proctitis < 5cm
- Live within driving distance of clinical site (to attend multiple study visits)
Key exclusion criteria (7 listed)
- Pregnancy
- Active gastrointestinal infection
- Other gastrointestinal disease / comorbidities
- Prior colonic surgery
- Recent antibiotic or probiotic use
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 |
|---|---|---|
| FMT infusionsActive FMT derived from healthy anonymous pre-screened donors | Biological | FMT infusions |
| Placebo infusionPlacebo infusion not containing any donor microbial material | Other | Placebo arm |
Primary outcome
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Time frame: 8 weeks
6 secondary outcomes
Clinical remission as measured by Mayo subscores
Time frame: 8 weeks
Clinical response as measured by Mayo subscores
Time frame: 8 weeks
Endoscopic healing as measured by UCEIS
Time frame: 8 weeks
Treatment failure rate as defined by Mayo subscores
Time frame: 8 weeks
Quality of life as measured by IBDQ
Time frame: 8 weeks
Safety and tolerability as measured by adverse event data
Time frame: 8 weeks
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 25 Oct 2016.
- Derived from this study: PubMed 30529583Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO. Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Gastroenterology. 2019 Apr;156(5):1440-1454.e2. doi: 10.1053/j.gastro.2018.12.001. Epub 2018 Dec 6.
- Derived from this study: PubMed 28214091Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
- Derived from this study: PubMed 26478682Paramsothy S, Walsh AJ, Borody T, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush NO, Kamm MA. Gastroenterologist perceptions of faecal microbiota transplantation. World J Gastroenterol. 2015 Oct 14;21(38):10907-14. doi: 10.3748/wjg.v21.i38.10907.
- Derived from this study: PubMed 26070003Paramsothy S, Borody TJ, Lin E, Finlayson S, Walsh AJ, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush N, Kamm MA. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis. 2015 Jul;21(7):1600-6. doi: 10.1097/MIB.0000000000000405.
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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.
Hazel Mitchell, BSc PhD principal investigator
University of New South Wales
Alissa Walsh, MBBS principal investigator
St Vincent's Hospital, Sydney
Johan van den Bogaerde, MBChB PhD principal investigator
Nambour General Hospital, Queensland
3 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 FMT infusions in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by The University of New South Wales at 3 sites in Australia.
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 4 inclusion and 7 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (time frame: 8 weeks). 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 NCT01896635, which also lists 4 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 25 Oct 2016.