Findings from a Randomized Controlled Trial of Fecal Transplantation for Patients with Ulcerative Colitis
| Autor: | Willem M. de Vos, Jorn H. A. Hartman, Geert R. D'Haens, Noortje G. Rossen, Jan G. Tijssen, Mirjam van der Spek, Mark Löwenberg, Elisabeth M. H. Mathus-Vliegen, Susana Fuentes, Gijs R. van den Brink, Cyriel Y. Ponsioen, Ann Duflou, Erwin G. Zoetendal |
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| Přispěvatelé: | Other departments, Cardiology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, AII - Amsterdam institute for Infection and Immunity |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Gastroenterology Inflammatory bowel disease Microbiology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Interquartile range law Microbiologie Internal medicine Clinical endpoint Medicine Data monitoring committee Adverse effect 030304 developmental biology VLAG 0303 health sciences Intention-to-treat analysis Hepatology business.industry Inflammatory Bowel Disease Fecal Microbiota Transplantation medicine.disease Ulcerative colitis 3. Good health Surgery Randomized Controlled Trial 030211 gastroenterology & hepatology business |
| Zdroj: | Gastroenterology, 149(1), 110-118 Gastroenterology 149 (2015) 1 Gastroenterology, 149(1), 110-118.e4. W.B. Saunders Ltd |
| ISSN: | 0016-5085 |
| DOI: | 10.1053/j.gastro.2015.03.045 |
| Popis: | Background & Aims Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. Methods Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples. Results Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point ( P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point ( P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa. Conclusions In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038. |
| Databáze: | OpenAIRE |
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