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| Name | Class |
|---|---|
| Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine | UNKNOWN |
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Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) that almost always affects the rectum and often extends to the more proximal colon. UC usually begins at a young age (15-30 years), most patients (~ 85%) have a mild or moderate activity, characterized by periods of exacerbation and remission. Considering the important pathogenetic role of gut dysbiosis, recently, as an additional method of treating UC, it is considered a modification of altered gut microbiota using various drug and non-drug methods. One such method is fecal microbiota transplantation (FMT), consisting of the simultaneous replacement of the gut microbiota of a sick recipient with fecal material from a healthy donor. Even though so far the only officially approved indication for FMT is recurrent Clostridium difficile infection, however, the effectiveness of FMT is currently being studied in the treatment of other gastrointestinal and non-gastrointestinal pathologies, including UC. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT in UC, showing encouraging results. This study aimed to assess the clinical and microbiological efficacy, tolerability, and safety of FMT as add-on therapy to basic therapy, in patients with mild-to-moderate UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care group | Active Comparator | mesalazine (Pentasa) at a daily dose of 3 g (2 g orally + 1 g rectally) |
|
| Fecal transplantation | Experimental | Fecal transplantation of fresh prepared feces from healthy donor. Application by colonoscope in proximal half of colon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalazine | Drug | daily dose of 3 g (2 g orally + 1 g rectally) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in partial Mayo score > 2 points | Partial Mayo score composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. Partial Mayo score (eliminates endoscopy) and of 2 to 4 points indicates mildly active disease, a score of 5 to 6 points indicates moderately active disease, and a score of 7 to 9 points indicates severely active disease | 8 weeks |
| Changes in fecal calprotectin | expressed in µg/g | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome profile change | Characterization of fecal microbiome by metagenomic analysis before and after intervention Characterization of fecal microbiome by metagenomic analysis before and after intervention | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogomolets National Medical University | Kyiv | 01601 | Ukraine | |||
| Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36714101 | Derived | Tkach S, Dorofeyev A, Kuzenko I, Falalyeyeva T, Tsyryuk O, Kovalchuk O, Kobyliak N, Abenavoli L, Boccuto L. Efficacy and safety of fecal microbiota transplantation via colonoscopy as add-on therapy in patients with mild-to-moderate ulcerative colitis: A randomized clinical trial. Front Med (Lausanne). 2023 Jan 12;9:1049849. doi: 10.3389/fmed.2022.1049849. eCollection 2022. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Fecal transplantation | Biological | Preparation of fresh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of UC patient by colonoscopy after standard bowel preparation. |
|
| Kyiv |
| Ukraine |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |