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Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).
FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.
Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.
At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.
Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT from a healthy donor | Active Comparator | Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
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| FMT from a self donated stool sample | Placebo Comparator | Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | Fecal microbiota transplantation through colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE | 8 weeks after FMT |
| Measure | Description | Time Frame |
|---|---|---|
| Histological remission assessed by sigmoidoscopy | Will be assessed by sigmoidoscopy | 8 weeks after FMT |
| Long term remission assessed through questionnaires | Will be assessed through questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroentherology | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D005773 | Gastroscopy |
| D000069467 | Fecal Microbiota Transplantation |
| D004733 | Enema |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Gastroscopy | Procedure | Fecal microbiota transplantation through gastroscopy |
|
| Fecal Microbiota | Drug |
|
| Enema | Procedure | Fecal microbiota transplantation through enema |
|
| one year after FMT |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |