Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis

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, 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

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).

Conclusion: 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.

Keywords: Colitis, ulcerative; Escherichia coli Nissle 1917; Quality of life.

Conflict of interest statement

This study was supported by a research grant from BL&H Co., Ltd.

Figures

Figure 1
Figure 1
Flow chart of the process of patient enrolment. EcN, Escherichia coli Nissle 1917.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9449212/bin/kjim-2021-458f2.jpg

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