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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 54 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Lepistö, PhD, MD | Department of Gastrointestinal Surgery, Helsinki University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33501942 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Donors Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: 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. |
| FG001 | Patients Own Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donors Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 52 weeks |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donors Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Essi Karjalainen | Department of Gastrointestinal surgery, Helsinki University Hospital | +358504621853 | essi.karjalainen@hus.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2018 | Mar 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019449 | Pouchitis |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| Placebo | Biological | 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. |
|
| BG001 | Patients Own Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Antibiotic use at time of study enrollment | Count of Participants | Participants |
|
| Probiotics | Count of Participants | Participants |
|
| OG001 | Patients Own Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. 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. |
|
|
|
| Secondary | 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. | Not Posted | 54 weeks | Participants |
| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | Patients Own Feces | Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. 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. | 0 | 13 | 0 | 13 | 1 | 13 |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| fecal urgency | Gastrointestinal disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |
| D003092 | Colitis |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |