Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis
Background/Aims In ulcerative colitis (UC) patients, Escherichia coli Nissle 1917 (EcN) is equivalent to mesalazine for preventing disease relapse; however, evidence of the ability of EcN to increase health-related quality of life or induce remission remains scarce. We investigated the efficacy of E...
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| Format: | Article |
| Language: | English |
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The Korean Association of Internal Medicine
2022-09-01
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| Series: | The Korean Journal of Internal Medicine |
| Subjects: | |
| Online Access: | http://kjim.org/upload/pdf/kjim-2021-458.pdf |
| _version_ | 1798031979637112832 |
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| author | Soo-Kyung Park Sang-Bum Kang SangSoo Kim Tae Oh Kim Jae Myung Cha Jong Pil Im Chang Hwan Choi Eun Soo Kim Geom Seog Seo Chang Soo Eun Dong Soo Han Dong Il Park |
| author_facet | Soo-Kyung Park Sang-Bum Kang SangSoo Kim Tae Oh Kim Jae Myung Cha Jong Pil Im Chang Hwan Choi Eun Soo Kim Geom Seog Seo Chang Soo Eun Dong Soo Han Dong Il Park |
| author_sort | Soo-Kyung Park |
| collection | DOAJ |
| description | Background/Aims In ulcerative colitis (UC) patients, Escherichia coli Nissle 1917 (EcN) is equivalent to mesalazine for preventing disease relapse; however, evidence of the ability of EcN to increase health-related quality of life or induce remission remains scarce. We investigated the efficacy of EcN as an add-on therapy for UC. Methods In this multicentre, double-blind, randomised, placebo-controlled study, a total of 133 UC patients were randomly assigned to receive either EcN or placebo once daily for 8 weeks. Inflammatory bowel disease questionnaire (IBDQ) scores (primary endpoint) and clinical remission and response rates (secondary endpoints) were compared (Clinical trial registration number: NCT04969679). Results In total, 118 patients (EcN, 58; placebo, 60) completed the study. The number of patients reaching the primary endpoint did not differ between the EcN and placebo groups (30 [51.7%] vs. 31 [51.7%]; per-protocol analysis, p = 1.0; intention-to-treat analysis, p = 0.86). However, significantly fewer patients in the EcN group exhibited a decreased IBDQ score (1 [1.7%] vs. 8 [13.3%]; per-protocol analysis, p = 0.03; intention-to-treat analysis, p = 0.02). Moreover, a significantly higher number of patients in the EcN group displayed clinical response at 4 weeks (23 [39.7%] vs. 13 [21.7%], p = 0.04) and endoscopic remission at 8 weeks (26 [46.4%] vs. 16 [27.1%], p = 0.03). Conclusions Although the number of patients reaching the primary endpoint did not differ between the EcN and placebo groups, EcN was found to be safe and effective in preventing the exacerbation of IBDQ scores and achieving clinical responses and endoscopic remission in patients with mild-to-moderate UC. |
| first_indexed | 2024-04-11T20:05:27Z |
| format | Article |
| id | doaj.art-fc0af95adfb249c49ffee3f2ad9797fb |
| institution | Directory Open Access Journal |
| issn | 1226-3303 2005-6648 |
| language | English |
| last_indexed | 2024-04-11T20:05:27Z |
| publishDate | 2022-09-01 |
| publisher | The Korean Association of Internal Medicine |
| record_format | Article |
| series | The Korean Journal of Internal Medicine |
| spelling | doaj.art-fc0af95adfb249c49ffee3f2ad9797fb2022-12-22T04:05:20ZengThe Korean Association of Internal MedicineThe Korean Journal of Internal Medicine1226-33032005-66482022-09-0137594995710.3904/kjim.2021.458170667Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitisSoo-Kyung Park0Sang-Bum Kang1SangSoo Kim2Tae Oh Kim3Jae Myung Cha4Jong Pil Im5Chang Hwan Choi6Eun Soo Kim7Geom Seog Seo8Chang Soo Eun9Dong Soo Han10Dong Il Park11 Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Division of Gastroenterology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea Department of Bioinformatics, Soongsil University, Seoul, Korea Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University School of Medicine, Iksan, Korea Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, KoreaBackground/Aims In ulcerative colitis (UC) patients, Escherichia coli Nissle 1917 (EcN) is equivalent to mesalazine for preventing disease relapse; however, evidence of the ability of EcN to increase health-related quality of life or induce remission remains scarce. We investigated the efficacy of EcN as an add-on therapy for UC. Methods In this multicentre, double-blind, randomised, placebo-controlled study, a total of 133 UC patients were randomly assigned to receive either EcN or placebo once daily for 8 weeks. Inflammatory bowel disease questionnaire (IBDQ) scores (primary endpoint) and clinical remission and response rates (secondary endpoints) were compared (Clinical trial registration number: NCT04969679). Results In total, 118 patients (EcN, 58; placebo, 60) completed the study. The number of patients reaching the primary endpoint did not differ between the EcN and placebo groups (30 [51.7%] vs. 31 [51.7%]; per-protocol analysis, p = 1.0; intention-to-treat analysis, p = 0.86). However, significantly fewer patients in the EcN group exhibited a decreased IBDQ score (1 [1.7%] vs. 8 [13.3%]; per-protocol analysis, p = 0.03; intention-to-treat analysis, p = 0.02). Moreover, a significantly higher number of patients in the EcN group displayed clinical response at 4 weeks (23 [39.7%] vs. 13 [21.7%], p = 0.04) and endoscopic remission at 8 weeks (26 [46.4%] vs. 16 [27.1%], p = 0.03). Conclusions Although the number of patients reaching the primary endpoint did not differ between the EcN and placebo groups, EcN was found to be safe and effective in preventing the exacerbation of IBDQ scores and achieving clinical responses and endoscopic remission in patients with mild-to-moderate UC.http://kjim.org/upload/pdf/kjim-2021-458.pdfescherichia coli nissle 1917colitisulcerativequality of life |
| spellingShingle | Soo-Kyung Park Sang-Bum Kang SangSoo Kim Tae Oh Kim Jae Myung Cha Jong Pil Im Chang Hwan Choi Eun Soo Kim Geom Seog Seo Chang Soo Eun Dong Soo Han Dong Il Park Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis The Korean Journal of Internal Medicine escherichia coli nissle 1917 colitis ulcerative quality of life |
| title | Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis |
| title_full | Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis |
| title_fullStr | Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis |
| title_full_unstemmed | Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis |
| title_short | Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis |
| title_sort | additive effect of probiotics mutaflor on 5 aminosalicylic acid therapy in patients with ulcerative colitis |
| topic | escherichia coli nissle 1917 colitis ulcerative quality of life |
| url | http://kjim.org/upload/pdf/kjim-2021-458.pdf |
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