Ulcerative ColitisPhase 2FACTUNCT03104036
Faecal Bacteriotherapy for Ulcerative Colitis
A Phase 2 study testing Faecal bacterial transplantation and Mesalazine 4G Enema in people with Ulcerative Colitis, run by Institute for Clinical and Experimental Medicine at 9 sites in Czechia.
Trial summary
The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Faecal bacterial transplantation and Mesalazine 4G Enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 9 sitesCzechia
- Study dates
- 19 Jun 2017to 30 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left-sided ulcerative colitis > 15cm ongoing more than 3 month
- Mayo score < 10
- Endoscopic Mayo score ≥ 2
Who cannot join
- Anti-TNF medication in the previous 6 months
- Cyclosporine in the previous 4 weeks
- Methotrexate in the previous 2 months
- Prednisone > 10mg
- The real risk of colectomy in the near future
- Positive stool culture (Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli)
- CMV infection
- Pregnancy, breastfeeding women
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Czechia9 sites
Gastroenterology departement Hospital České Budějovice
České Budějovice, South Bohemian Region, 370 01
Second department of internal medicine of University Hospital Olomouc
Olomouc, Olomouc Region, 77900
Centrum péče o zažívací trakt Vítkovická nemocnice
Ostrava - Vitkovice, Moravian-Silesian Region, 703 84
IV. Department of Internal Medicine, General University Hospital in Prague
Prague, Prague 2, 128 08
Internal departement of Thomayer Hospital
Prague, Prague 4, 14059
ISCARE
Prague, Prague 7, 17004
II. Department of Internal Medicine University Hospital Vinohrady
Prague, 100 34
Institute of clinical and experimental medicine
Prague, 14021
Internal departement Hospital Na Bulovce
Prague, 150 00
About this study
The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent.
The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.
- Conditions
- Ulcerative Colitis
- Being tested
- Faecal bacterial transplantation, Mesalazine 4G Enema
- Keywords
- Feacal bacterial transplantation, Left-sided 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.
Faecal bacterial transplantationOther
Also called FMT
Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
Mesalazine 4G EnemaDrug
Standard mesalazine enema
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine enema | Active comparator | Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. Receives: Drug: Mesalazine 4G Enema |
| Faecal bacterial transplantation enema | Experimental | Will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week. Receives: Other: Faecal bacterial transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Mayo score ≤ 2 with no subscore > 1
Measured: Week 12
Secondary outcomes (2)
Endoscopic remission
Mayo endoscopic score = 0
Measured: Week 6 and 12
Clinical response
Decrease of Mayo score ≥ 2
Measured: Week 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start19 Jun 2017
- Primary completion30 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Institute of Animal Physiology and Genetics Academy of Science Czech Republic
- Responsible party
- Principal investigator, Jan Březina, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104036
- Sponsor's protocol ID
- F16-27449A
- Acronym
- FACTU
- Status last verified
- Sep 2021
- First submitted
- 27 Mar 2017
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Bacteriotherapy for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03104036
- Acronym / sponsor ID
- FACTU / F16-27449A
- Conditions
- Ulcerative Colitis
- Keywords
- Feacal bacterial transplantation, Left-sided ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Institute of Animal Physiology and Genetics Academy of Science Czech Republic
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 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 etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent.
The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.
| Arm | Type | Receives |
|---|---|---|
| Mesalazine enema | Active comparator | Drug: Mesalazine 4G EnemaWill be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. |
| Faecal bacterial transplantation enema | Experimental | Other: Faecal bacterial transplantationWill be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left-sided ulcerative colitis > 15cm ongoing more than 3 month
- Mayo score < 10
- Endoscopic Mayo score ≥ 2
Key exclusion criteria (8 listed)
- Anti-TNF medication in the previous 6 months
- Cyclosporine in the previous 4 weeks
- Methotrexate in the previous 2 months
- Prednisone > 10mg
- The real risk of colectomy in the near future
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 |
|---|---|---|
| Faecal bacterial transplantationAlso: FMTEnema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline | Other | Faecal bacterial transplantation enema |
| Mesalazine 4G EnemaStandard mesalazine enema | Drug | Mesalazine enema |
Primary outcome
Clinical remission
Time frame: Week 12
Mayo score ≤ 2 with no subscore > 1
2 secondary outcomes
Endoscopic remission
Time frame: Week 6 and 12
Clinical response
Time frame: Week 6 and 12
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 1 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Faecal bacterial transplantation and Mesalazine 4G Enema in people with Ulcerative Colitis, run by Institute for Clinical and Experimental Medicine at 9 sites in Czechia.
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 3 inclusion and 8 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Czechia. 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. 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 remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2021.