Crohn DiseasePhase 2NCT03078803
Fecal Transplant for Crohn's Disease
A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Crohn Disease, run by University of Alberta at 3 sites in Canada.
Trial summary
To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 3 sitesCanada
- Study dates
- 28 Mar 2017to 29 Aug 2022
- 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
- mild to moderate ileal, ileo-colonic or colonic Crohns disease
- active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
- If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
- Use of effective contraception
Who cannot join
- Antibiotic exposure within 30 days and probiotic exposure within 14 days
- topical inflammatory bowel disease therapy within 2 weeks
- active perianal disease
- requirement for concurrent antibiotic therapy
- SES-CD score <5
- severe CD HBI >25 or need for hospitalization
Show all 19Show fewer
- abdominal abscess
- extensive colonic resection, subtotal or total colectomy
- ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
- evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
- requiring or expected to require surgical intervention
- history or evidence of adenomatous colonic polyps not removed
- history of evidence of colonic dysplasia
- active substance abuse or psychiatric problems that may interfere with study
- chronic Hep B, C, or HIV infection
- pregnancy or planning to become pregnant
- upper CD
- history of adhesions preventing colonoscopy to cecum
- planned bowel resection within 3 mon of enrollment
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Hospital
Calgary, Alberta, T2N2T9
University of Alberta
Edmonton, Alberta, T6G 2X8
McMaster University
Hamilton, Ontario
About this study
Official title: A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease
Read the detailed description
Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
- Conditions
- Crohn Disease
- Being tested
- Fecal Microbiota Transplant (FMT), Placebo
- Keywords
- fecal transplant, inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Biological
Also called FMT
FMT delivered by colonoscopy and oral capsules
PlaceboBiological
Transfer of water only
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplant | Experimental | Transfer of healthy human gut bacteria Receives: Biological: Fecal Microbiota Transplant (FMT) |
| Placebo | Placebo comparator | Water Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Endoscopic Remission
Harvey Bradshaw Index <5 and Simple endoscopic score <5
Measured: Week 8
Secondary outcomes (7)
Clinical response
Harvey Bradshaw Index reduction by 3 points
Measured: Week 8
Clinical remission
Harvey Bradshaw Index <5
Measured: Week 8
Endoscopic response
Simple endoscopic score reduction by 50%
Measured: Week 8
Endoscopic remission
Simple endoscopic score <5
Measured: Week 8
Quality of Life 1
Mean changes in Short Inflammatory Bowel Disease Questionnaire
Measured: Week 8
Quality of Life 2
Mean changes in Euro five dimensions questionnaire
Measured: Week 8
Quality of Life 3
Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start28 Mar 2017
- Primary completion21 Jun 2021
- Study completion29 Aug 2022
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 Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, McMaster University
- Responsible party
- Sponsor
- Investigators
- Dina Kao, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078803
- Sponsor's protocol ID
- 66218
- Status last verified
- Sep 2022
- First submitted
- 12 Jan 2017
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196.
PubMed 39530534
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
- ClinicalTrials.gov ID
- NCT03078803
- Acronym / sponsor ID
- 66218
- Conditions
- Crohn Disease
- Keywords
- fecal transplant, inflammatory bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, McMaster University
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease
Detailed description
Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
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 |
|---|---|---|
| Fecal microbiota transplant | Experimental | Biological: Fecal Microbiota Transplant (FMT)Transfer of healthy human gut bacteria |
| Placebo | Placebo comparator | Biological: PlaceboWater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mild to moderate ileal, ileo-colonic or colonic Crohns disease
- active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
- If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
- Use of effective contraception
Key exclusion criteria (19 listed)
- Antibiotic exposure within 30 days and probiotic exposure within 14 days
- topical inflammatory bowel disease therapy within 2 weeks
- active perianal disease
- requirement for concurrent antibiotic therapy
- SES-CD score <5
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 Transplant (FMT)Also: FMTFMT delivered by colonoscopy and oral capsules | Biological | Fecal microbiota transplant |
| PlaceboTransfer of water only | Biological | Placebo |
Primary outcome
Clinical and Endoscopic Remission
Time frame: Week 8
Harvey Bradshaw Index <5 and Simple endoscopic score <5
7 secondary outcomes
Clinical response
Time frame: Week 8
Clinical remission
Time frame: Week 8
Endoscopic response
Time frame: Week 8
Endoscopic remission
Time frame: Week 8
Quality of Life 1
Time frame: Week 8
Quality of Life 2
Time frame: Week 8
Quality of Life 3
Time frame: Week 8
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 7 Sep 2022.
- Derived from this study: PubMed 39530534Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196.
- 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.
Dina Kao, MD principal investigator
University of Alberta
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 Fecal Microbiota Transplant (FMT) in people with Crohn Disease, run by University of Alberta at 3 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 4 inclusion and 19 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 7 Sep 2022. 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 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?
Clinical and Endoscopic Remission (time frame: Week 8). 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 NCT03078803, 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 7 Sep 2022.