PouchitisPhase 2NCT03378921
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
A Phase 2 study testing Fecal microbiota transplantation in people with Pouchitis and Ulcerative Colitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pouchitis, Ulcerative Colitis
- What is being tested?
- Fecal microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 27 Feb 2018to 25 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
- Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
- Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
- Availability of consecutive fecal samples during one year
- Compliance to attend FMT and control pouchoscopy after 52 weeks
Who cannot join
- Unable to provide informed consent
- Use of immunosuppressive or biological medication
- Use of corticosteroids
- Acute pouchitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.
Read the detailed description
Pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The etiology of pouchitis remains unclear. There is significant clinical evidence implicating bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile -infection. Case reports have also shown promising results of FMT in patients with inflammatory bowel disease. Currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in IPAA patients.
Patients receive FMTs on weeks 0 and 4. Antibiotic treatment has been stopped 36 hours before the first FMT.
- Conditions
- Pouchitis, Ulcerative Colitis
- Being tested
- Fecal microbiota transplantation, Placebo
- Keywords
- FMT
- Medical subject headings
- Pouchitis, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationBiological
Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
PlaceboBiological
Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
| Study group | Role | What they receive |
|---|---|---|
| donors feces | Experimental | Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT. Receives: Biological: Fecal microbiota transplantation |
| patients own feces | Placebo comparator | Fecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index <7 and no need for antibiotic treatment for pouchitis during the follow up
Measured: 52 weeks
Secondary outcomes (1)
Evaluation of the Changes in Gut Microbiota
Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start27 Feb 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essi Karjalainen, Helsinki University Central Hospital
- Investigators
- Anna Lepistö, PhD, MD, Study director, Department of Gastrointestinal Surgery, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378921
- Sponsor's protocol ID
- HelsinkiFMT
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2017
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karjalainen EK, Renkonen-Sinisalo L, Satokari R, Mustonen H, Ristimaki A, Arkkila P, Lepisto AH. Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial. Inflamm Bowel Dis. 2021 Oct 20;27(11):1766-1772. doi: 10.1093/ibd/izab001.
PubMed 33501942
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
- ClinicalTrials.gov ID
- NCT03378921
- Acronym / sponsor ID
- HelsinkiFMT
- Conditions
- Pouchitis, Ulcerative Colitis
- Keywords
- FMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 28 Apr 2021
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 our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.
Detailed description
Pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The etiology of pouchitis remains unclear. There is significant clinical evidence implicating bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile -infection. Case reports have also shown promising results of FMT in patients with inflammatory bowel disease. Currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in IPAA patients.
Patients receive FMTs on weeks 0 and 4. Antibiotic treatment has been stopped 36 hours before the first FMT.
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 |
|---|---|---|
| donors feces | Experimental | Biological: Fecal microbiota transplantationFecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT. |
| patients own feces | Placebo comparator | Biological: PlaceboFecal microbiota transplantation (FMT) is performed by experienced endoscopists through flexible endoscopy into the afferent limb. The second FMT is installed via transanal catheter into the pouch 4 weeks after the first FMT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
- Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
- Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
- Availability of consecutive fecal samples during one year
- Compliance to attend FMT and control pouchoscopy after 52 weeks
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Use of immunosuppressive or biological medication
- Use of corticosteroids
- Acute pouchitis
- Pregnancy
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 transplantationFollow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52. | Biological | donors feces |
| PlaceboFollow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52. | Biological | patients own feces |
Primary outcome
Clinical Remission
Time frame: 52 weeks
Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index <7 and no need for antibiotic treatment for pouchitis during the follow up
1 secondary outcome
Evaluation of the Changes in Gut Microbiota
Time frame: 54 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33501942Karjalainen EK, Renkonen-Sinisalo L, Satokari R, Mustonen H, Ristimaki A, Arkkila P, Lepisto AH. Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial. Inflamm Bowel Dis. 2021 Oct 20;27(11):1766-1772. doi: 10.1093/ibd/izab001.
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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.
Anna Lepistö, PhD, MD study director
Department of Gastrointestinal Surgery, Helsinki University Hospital
1 site 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 transplantation in people with Pouchitis and Ulcerative Colitis, run by Helsinki University Central Hospital at 1 site in Finland.
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 5 inclusion and 5 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 28 Apr 2021. 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 Finland. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 52 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 NCT03378921, 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 28 Apr 2021.