Ulcerative ColitisRESTORE-UCNCT03110289
Restoration of the Microbiome Through Superdonor Selection
A study testing superdonor FMT and autologous FMT in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The AIM of this study is to investigate whether the FMT success rate in active UC patients can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by repeated FMT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- superdonor FMT and autologous FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Apr 2017to 30 Apr 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients with currently mild-moderate active ulcerative colitis (defined by endoscopic Mayo sub score 2-3 and a Total Mayo score between 4-10)
- Provide written informed consent to participate as shown by a signature on the consent form.
- Patients on concomitant UC-therapy are allowed if the concomitant treatment is restricted to current treatment and at a stable dose (not in the induction faze).
- Topical therapy and trial medication is not allowed.
- A maximum dose of 15mg methylprednisolone.
- Negative coproculture (Salmonella, Shigella, Yersinia, Campylobacter, Entamoeba histoliytica, Clostridium difficile toxins and enteropathogenic E. coli)
- Women need to use reliable contraceptives during participation in the study
Who cannot join
- Consent not obtained or unable to give informed consent
- Condition leading to profound immunosuppression
- For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis
- Use of systemic chemotherapy
- Use of antibiotics in the previous 4 weeks
- Surgery: Total colectomy, presence of a stoma or ileo-anal pouch
Show all 13Show fewer
- Presence of an intra-abdominal fistula
- Colon carcinoma
- Diverticulitis
- Patients who are steroid dependent and requiring >15mg methyl prednisone 2 week before START.
- Detection of a gastrointestinal pathogen on stool analysis
- A diagnosis of Crohn's disease of indeterminate colitis
- Females who are pregnant or actively trying to fall pregnant
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3010
Clara Caenepeel, MD
About this study
Official title: Fecal Microbiota Transplantation in Patients With Active Ulcerative Colitis: Restoration of the Microbiome Through Superdonor Selection
The AIM of this study is to investigate whether the FMT success rate in active UC patients can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by repeated FMT.
The investigators will start a national multi-centre double-blind randomized sham-controlled trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham). Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be derived from one donor. Donors will be pre-selected based on a species richness and abundance of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different time points. 16S rRNA stool analysis will be performed to assess the microbial changes after FMT.
Read the detailed description
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD) characterized by a diffuse mucosal inflammation, extending proximally from the rectum and causing symptoms of bloody diarrhea. The complex pathogenesis of IBD remains largely unknown.
Manipulation of the enteric microbiota to restore normobiosis has therapeutic potential in IBD. Fecal microbiota transplantation (FMT), whereby fecal microbiota from a healthy donor is transplanted to a patient, is being studied as therapy for active UC patients. Currently three randomized controlled FMT trials have been published in patients with active ulcerative colitis with increasing success9-11. The investigators feel that the FMT success rate in active UC patients can be improved by solving the remaining pressing questions including the use of selected donors, preparation of the FMT, mode and frequency of administration. The investigators therefore designed a new multicenter interventional study with FMT to specifically answer these questions.
The overall main aims of this project are:
Objective 1: They want to examine whether the FMT success rate in active UC patients can be increased by strictly pre-selecting the donors, by standardizing and optimizing the FMT preparation and by repeated FMT administration.
Objective 2: The investigators want to investigate the temporal and functional changes of the intestinal microbiota of UC patients after FMT
Objective 3: They will try to define host-related predictors for (non-)response to FMT with integration of the genetic susceptibility of the patients and their baseline mucosal gene expression
Study design:
This will be a national multicenter (6 university centers) double blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of FMT in active UC patients (Mayo endoscopic sub score: 2 or 3 and Total Mayo score: 4-10).
The primary endpoint will be steroid-free clinical and endoscopic remission at week 8 (defined as a total Mayo score of 2 or less, with all Mayo subscores of 1 or less, and at least a 1 point reduction from baseline in the endoscopy subscore).
The secondary endpoints will be the investigation of changes in blood and fecal inflammatory markers before and after FMT (e.g. calprotectin and C-reactive protein (CRP)), steroid-free clinical remission, steroid-free clinical response, steroid-free endoscopic remission and steroid-free endoscopic response.
Assuming a success rate of 40% to achieve mucosal healing at week 8 in the donor FMT arm, a treatment difference of 25% in the autologous FMT arm, a sample size of 49 patients per group is required to obtain a power of 80% and a statistical significance at the 5% level. In addition, considering 10% dropouts, a total of 108 patients will be included. Two interim analysis will be performed after inclusion of respectively 33% and 66% of the sample size (N=108) at week 8.
A data and safety monitoring board (DSMB) can than give advice on adjustment of the sample size or early termination.
Fecal, blood, mucosal samples and questionnaires will be collected by the investigators at different time points.
Baseline fecal samples from donors and baseline mucosal samples together with fecal samples (at start of the study and at weeks 0, 1, 2, 3, 4, 8, 12, 24, 52) from patients will be studied by 16S rDNA sequencing based analysis of microbiota.
The goal of the investigators is to improve FMT success rates by microbial prescreening of the donor and by repeated FMT (4 FMT's/patient).
Prior to FMT, donor stool and blood will be screened for pathogens according to the international consensus guidelines. Furthermore, the investigators will pre-select their donors based on species richness and abundance of taxa of interest.
One donor per ten patients will be used and fecal material will be frozen at -80° until use. Therefore the investigators need at least 15 donors to provide fecal samples during the whole trial, inclusive the open-label faze ( +/- 600 donor samples in total).
To optimize the FMT preparation the investigators will prepare the FMT samples under strict anaerobic circumstances.
To standardize the FMT preparation an absolute cell count of the fecal suspension will be determined after a first dilution.
Repeated FMT will be performed for four times with an interval of 1 week until week 4. At baseline, patients will drink 2L Moviprep (standard preparation), afterwards a sigmoidoscopy will be performed whereby the donor feces solution will be administered through a rectal tube.
At week 1, 2 and 3, the donor feces solution will be administered through rectal instillation without prior water enema.
Open label FMT will be available for all patients in the sham-FMT arm from week 8.
- Conditions
- Ulcerative Colitis
- Being tested
- superdonor FMT, autologous FMT
- Keywords
- 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.
superdonor FMTOther
Fecal microbiota transplantation (FMT) is the transfer of feces from a healthy "superdonor" to the patient.
autologous FMTOther
Fecal microbiota transplantation (FMT) with feces from the patient him/herself
| Study group | Role | What they receive |
|---|---|---|
| Superdonor FMT | Experimental | Fecal microbiota transplantation from a healthy donor that was selected based on a fecal/blood screening, medical interview and on abundance of taxa of the investigators their interest Receives: Other: superdonor FMT |
| Autologous FMT | Sham comparator | Fecal microbiota transplantation derived from feces from the patient her/himself. Receives: Other: autologous FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
steroid-free clinical remission
defined as a total Mayo score of 2 or less and with all Mayo subscores of 1 or less.
Measured: Week 8
steroid-free endoscopic remission or response
defined as at least a 1 point reduction from baseline in the endoscopy subscore.
Measured: Week 8
Secondary outcomes (5)
the investigation of changes in blood and fecal inflammatory markers before and after FMT
changes in calprotectin and C-reactive protein (CRP)
Measured: Week 8
Steroid-free clinical remission
combined Mayo subscores of 1 or less for rectal bleeding plus stool frequency
Measured: Week 8
Steroid-free clinical response
a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo subscores, or both.
Measured: Week 8
Steroid-free endoscopic response
Mayo endoscopic subscore of 1 or less, with a reduction of at least 1 point from baseline
Measured: Week 8
Steroid-free endoscopic remission
Mayo endoscopy subscore of 0 or 1.
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 posted12 Apr 2017
- Study start30 Apr 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Model description
- We will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, Clara Caenepeel, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Séverine Vermeire, MD and PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110289
- Sponsor's protocol ID
- S59525
- Acronym
- RESTORE-UC
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caenepeel C, Deleu S, Vazquez Castellanos JF, Arnauts K, Braekeleire S, Machiels K, Baert F, Mana F, Pouillon L, Hindryckx P, Lobaton T, Louis E, Franchimont D, Verstockt B, Ferrante M, Sabino J, Vieira-Silva S, Falony G, Raes J, Vermeire S. Rigorous Donor Selection for Fecal Microbiota Transplantation in Active Ulcerative Colitis: Key Lessons From a Randomized Controlled Trial Halted for Futility. Clin Gastroenterol Hepatol. 2025 Mar;23(4):621-631.e7. doi: 10.1016/j.cgh.2024.05.017. Epub 2024 May 23.
PubMed 38788915
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients With Active Ulcerative Colitis: Restoration of the Microbiome Through Superdonor Selection
- ClinicalTrials.gov ID
- NCT03110289
- Acronym / sponsor ID
- RESTORE-UC / S59525
- Conditions
- Ulcerative Colitis
- Keywords
- Fecal microbiota transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 12 Apr 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.
The AIM of this study is to investigate whether the FMT success rate in active UC patients can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by repeated FMT.
The investigators will start a national multi-centre double-blind randomized sham-controlled trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham). Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be derived from one donor. Donors will be pre-selected based on a species richness and abundance of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different time points. 16S rRNA stool analysis will be performed to assess the microbial changes after FMT.
Detailed description
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD) characterized by a diffuse mucosal inflammation, extending proximally from the rectum and causing symptoms of bloody diarrhea. The complex pathogenesis of IBD remains largely unknown.
Manipulation of the enteric microbiota to restore normobiosis has therapeutic potential in IBD. Fecal microbiota transplantation (FMT), whereby fecal microbiota from a healthy donor is transplanted to a patient, is being studied as therapy for active UC patients. Currently three randomized controlled FMT trials have been published in patients with active ulcerative colitis with increasing success9-11. The investigators feel that the FMT success rate in active UC patients can be improved by solving the remaining pressing questions including the use of selected donors, preparation of the FMT, mode and frequency of administration. The investigators therefore designed a new multicenter interventional study with FMT to specifically answer these questions.
The overall main aims of this project are:
Objective 1: They want to examine whether the FMT success rate in active UC patients can be increased by strictly pre-selecting the donors, by standardizing and optimizing the FMT preparation and by repeated FMT administration.
Objective 2: The investigators want to investigate the temporal and functional changes of the intestinal microbiota of UC patients after FMT
Objective 3: They will try to define host-related predictors for (non-)response to FMT with integration of the genetic susceptibility of the patients and their baseline mucosal gene expression
Study design:
This will be a national multicenter (6 university centers) double blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of FMT in active UC patients (Mayo endoscopic sub score: 2 or 3 and Total Mayo score: 4-10).
The primary endpoint will be steroid-free clinical and endoscopic remission at week 8 (defined as a total Mayo score of 2 or less, with all Mayo subscores of 1 or less, and at least a 1 point reduction from baseline in the endoscopy subscore).
The secondary endpoints will be the investigation of changes in blood and fecal inflammatory markers before and after FMT (e.g. calprotectin and C-reactive protein (CRP)), steroid-free clinical remission, steroid-free clinical response, steroid-free endoscopic remission and steroid-free endoscopic response.
Assuming a success rate of 40% to achieve mucosal healing at week 8 in the donor FMT arm, a treatment difference of 25% in the autologous FMT arm, a sample size of 49 patients per group is required to obtain a power of 80% and a statistical significance at the 5% level. In addition, considering 10% dropouts, a total of 108 patients will be included. Two interim analysis will be performed after inclusion of respectively 33% and 66% of the sample size (N=108) at week 8.
A data and safety monitoring board (DSMB) can than give advice on adjustment of the sample size or early termination.
Fecal, blood, mucosal samples and questionnaires will be collected by the investigators at different time points.
Baseline fecal samples from donors and baseline mucosal samples together with fecal samples (at start of the study and at weeks 0, 1, 2, 3, 4, 8, 12, 24, 52) from patients will be studied by 16S rDNA sequencing based analysis of microbiota.
The goal of the investigators is to improve FMT success rates by microbial prescreening of the donor and by repeated FMT (4 FMT's/patient).
Prior to FMT, donor stool and blood will be screened for pathogens according to the international consensus guidelines. Furthermore, the investigators will pre-select their donors based on species richness and abundance of taxa of interest.
One donor per ten patients will be used and fecal material will be frozen at -80° until use. Therefore the investigators need at least 15 donors to provide fecal samples during the whole trial, inclusive the open-label faze ( +/- 600 donor samples in total).
To optimize the FMT preparation the investigators will prepare the FMT samples under strict anaerobic circumstances.
To standardize the FMT preparation an absolute cell count of the fecal suspension will be determined after a first dilution.
Repeated FMT will be performed for four times with an interval of 1 week until week 4. At baseline, patients will drink 2L Moviprep (standard preparation), afterwards a sigmoidoscopy will be performed whereby the donor feces solution will be administered through a rectal tube.
At week 1, 2 and 3, the donor feces solution will be administered through rectal instillation without prior water enema.
Open label FMT will be available for all patients in the sham-FMT arm from week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham)
| Arm | Type | Receives |
|---|---|---|
| Superdonor FMT | Experimental | Other: superdonor FMTFecal microbiota transplantation from a healthy donor that was selected based on a fecal/blood screening, medical interview and on abundance of taxa of the investigators their interest |
| Autologous FMT | Sham comparator | Other: autologous FMTFecal microbiota transplantation derived from feces from the patient her/himself. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Patients with currently mild-moderate active ulcerative colitis (defined by endoscopic Mayo sub score 2-3 and a Total Mayo score between 4-10)
- Provide written informed consent to participate as shown by a signature on the consent form.
- Patients on concomitant UC-therapy are allowed if the concomitant treatment is restricted to current treatment and at a stable dose (not in the induction faze).
- Negative coproculture (Salmonella, Shigella, Yersinia, Campylobacter, Entamoeba histoliytica, Clostridium difficile toxins and enteropathogenic E. coli)
Key exclusion criteria (13 listed)
- Consent not obtained or unable to give informed consent
- Condition leading to profound immunosuppression
- Use of antibiotics in the previous 4 weeks
- Surgery: Total colectomy, presence of a stoma or ileo-anal pouch
- Presence of an intra-abdominal fistula
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 |
|---|---|---|
| superdonor FMTFecal microbiota transplantation (FMT) is the transfer of feces from a healthy "superdonor" to the patient. | Other | Superdonor FMT |
| autologous FMTFecal microbiota transplantation (FMT) with feces from the patient him/herself | Other | Autologous FMT |
Primary outcome
steroid-free clinical remission
Time frame: Week 8
defined as a total Mayo score of 2 or less and with all Mayo subscores of 1 or less.
steroid-free endoscopic remission or response
Time frame: Week 8
defined as at least a 1 point reduction from baseline in the endoscopy subscore.
5 secondary outcomes
the investigation of changes in blood and fecal inflammatory markers before and after FMT
Time frame: Week 8
Steroid-free clinical remission
Time frame: Week 8
Steroid-free clinical response
Time frame: Week 8
Steroid-free endoscopic response
Time frame: Week 8
Steroid-free endoscopic remission
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 38788915Caenepeel C, Deleu S, Vazquez Castellanos JF, Arnauts K, Braekeleire S, Machiels K, Baert F, Mana F, Pouillon L, Hindryckx P, Lobaton T, Louis E, Franchimont D, Verstockt B, Ferrante M, Sabino J, Vieira-Silva S, Falony G, Raes J, Vermeire S. Rigorous Donor Selection for Fecal Microbiota Transplantation in Active Ulcerative Colitis: Key Lessons From a Randomized Controlled Trial Halted for Futility. Clin Gastroenterol Hepatol. 2025 Mar;23(4):621-631.e7. doi: 10.1016/j.cgh.2024.05.017. Epub 2024 May 23.
- 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.
Séverine Vermeire, MD and PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superdonor FMT and autologous FMT in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Mar 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 Belgium. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Caenepeel, MD (+32 16 32 51 48, clara.caenepeel@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
steroid-free clinical remission (time frame: Week 8). The study lists 2 primary outcomes in all. 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 NCT03110289, 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 Mar 2018.