Korean J Intern Med.
2022 Sep;37(5):949-957. 10.3904/kjim.2021.458.
Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis
- Affiliations
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- 1Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
- 2Division of Gastroenterology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea
- 3Department of Bioinformatics, Soongsil University, Seoul, Korea
- 4Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea
- 5Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea
- 6Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
- 7Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
- 8Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
- 9Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University School of Medicine, Iksan, Korea
- 10Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea
- KMID: 2533138
- DOI: http://doi.org/10.3904/kjim.2021.458
Abstract
- 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.
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