A Phase 2 interventional study of Fecal microbiota transplantation and Placebo in Pouchitis and Ulcerative Colitis, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Helsinki University Central Hospital · Phase 2, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's enrollment of 26 is above the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Fecal microbiota transplantation
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.
Biological: Placebo
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.
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.
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
Time frame: 52 weeks
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.
Time frame: 54 weeks
| Milestone | Donors Feces | Patients Own Feces |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
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
| Participants | Donors Feces | Patients Own Feces |
|---|---|---|
| Clinical Remission | 4 | 5 |
Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Results for this outcome have not been posted.
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Donors Feces | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Patients Own Feces | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Donors Feces | Patients Own Feces |
|---|---|---|
| feverGeneral disorders | 1/13 | 1/13 |
| abdominal painGastrointestinal disorders | 1/13 | 0/13 |
| fecal urgencyGastrointestinal disorders | 1/13 | 0/13 |
| Age, Continuous(years) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| Mean | 42.7 ± 10.2 | 45.5 ± 11.7 | 44.1 ± 10.9 |
| Sex: Female, Male(Participants) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 7 | 8 | 15 |
| Race and Ethnicity Not Collected(Participants) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| Finland | 13 | 13 | 26 |
| Antibiotic use at time of study enrollment(Participants) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| continuous use | 5 | 7 | 12 |
| repeated | 8 | 6 | 14 |
| Probiotics(Participants) | Donors Feces | Patients Own Feces | Total |
|---|---|---|---|
| Count of participants | 5 | 6 | 11 |
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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