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Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
| Content Provider | MDPI |
|---|---|
| Author | Jan, Březina Dana, Ďuricová Pavel, Hrabák Ale, š Novotný Jana, Koželuhová Milan, Lukáš Jakub, Mrázek Kate, řina Fliegerová Simona, Kvasnová Jan, Mareš Julius, Špičák Bajer, Lukáš Wohl, Pavel Chahrazed, Mekadim Drastich, Pavel |
| Copyright Year | 2021 |
| Description | Background and Aims: Ulcerative colitis (UC) is a chronic inflammatory disease. Fecal microbial transplantation (FMT) is a promising alternative treatment. Methods: This multicenter, open-label, noninferiority trial randomized patients with active left-sided UC (Mayo score 4–10) equally to FMT or 5-aminosalicylic acid (5-ASA) enemas. FMT enemas were administered five times in the first week and then once weekly for 5 weeks. 5-ASA enemas were administered daily for 2 weeks and then every other day. The primary study endpoint was clinical remission, with a total Mayo score ≤2 at week 12 with no subscore >1. Results: Sixty-one patients were screened; 45 were enrolled and randomized to FMT (n = 23) or 5-ASA (n = 22). Twenty-one FMT and 22 5-ASA patients completed at least the week 4 study visit and were included in the mITT analysis. Twelve FMT (57%) and eight 5-ASA patients achieved the primary study endpoint. FMT noninferiority with 10% margin was confirmed (95% CI: −7.6%, 48.9%). Adverse events occurred in 12 FMT (57%) and 13 5-ASA (59%) patients. Increased microbial diversity persisted 3 months after FMT. Conclusion: FMT is an effective treatment for left-sided UC and increased recipient microbiome diversity. Targeted microbiome modification may improve FMT efficacy. Further investigation is needed to guide donor and patient selection. |
| Starting Page | 2753 |
| e-ISSN | 20770383 |
| DOI | 10.3390/jcm10132753 |
| Journal | Journal of clinical medicine |
| Issue Number | 13 |
| Volume Number | 10 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2021-06-22 |
| Access Restriction | Open |
| Subject Keyword | Journal of clinical medicine Journal of Clinical Medicine Surgery Ulcerative Colitis Fecal Microbial Transplantation 5-aminosalicylic Acid |
| Content Type | Text |
| Resource Type | Article |
