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

被引：2

作者：

Park, Soo-Kyung ^{[1
]}

Kang, Sang-Bum ^{[2
]}

Kim, SangSoo ^{[3
]}

Kim, Tae Oh ^{[4
]}

Cha, Jae Myung ^{[5
]}

Im, Jong Pil ^{[6
,7
]}

Choi, Chang Hwan ^{[8
]}

Kim, Eun Soo ^{[9
]}

Seo, Geom Seog ^{[10
]}

Eun, Chang Soo ^{[11
]}

Han, Dong Soo ^{[11
]}

Park, Dong Il ^{[1
]}

机构：

[1] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Div Gastroenterol, Dept Internal Med,Sch Med, Seoul, South Korea

[2] Catholic Univ Korea, Daejeon St Marys Hosp, Div Gastroenterol, Dept Internal Med,Coll Med, Daejeon, South Korea

[3] Soongsil Univ, Dept Bioinformat, Seoul, South Korea

[4] Inje Univ, Dept Internal Med, Haeundae Paik Hosp, Busan, South Korea

[5] Kyung Hee Univ Hosp Gangdong, Dept Internal Med, Seoul, South Korea

[6] Seoul Natl Univ, Dept Internal Med, Coll Med, Seoul, South Korea

[7] Seoul Natl Univ, Liver Res Inst, Coll Med, Seoul, South Korea

[8] Chung Ang Univ, Dept Internal Med, Coll Med, Seoul, South Korea

[9] Kyungpook Natl Univ, Sch Med, Div Gastroenterol & Hepatol, Dept Internal Med, Daegu, South Korea

[10] Wonkwang Univ, Digest Dis Res Inst, Dept Internal Med, Sch Med, Iksan, South Korea

[11] Hanyang Univ, Dept Internal Med, Guri Hosp, Guri, South Korea

来源：

KOREAN JOURNAL OF INTERNAL MEDICINE | 2022年 / 37卷 / 05期

关键词：

Escherichia coli Nissle 1917; Colitis; ulcerative; Quality of life;

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：949 / +

页数：14