Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis: A double-blind randomized placebo controlled clinical trial

Andreas Munk Petersen; Hengameh Mirsepasi; Sofie Ingdam Halkjær; Esben Munk Mortensen; Inge Nordgaard-Lassen; Karen Angeliki Krogfelt

doi:10.1016/j.crohns.2014.06.001

Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis: A double-blind randomized placebo controlled clinical trial

Andreas Munk Petersen^*, Hengameh Mirsepasi, Sofie Ingdam Halkjær, Esben Munk Mortensen, Inge Nordgaard-Lassen, Karen Angeliki Krogfelt

^*Corresponding author for this work

60 Citations (Scopus)

Abstract

Background and aim: Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC. Patients and methods: Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1. week followed by EcN or placebo for 7. weeks. All 4 treatments were given as add-on treatments. Results: One hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p. <. 0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p. <. 0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p. <. 0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively. Conclusions: Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.

Original language	English
Journal	Journal of Crohn's and Colitis
Volume	8
Issue number	11
Pages (from-to)	1498-1505
Number of pages	8
ISSN	1873-9946
DOIs	https://doi.org/10.1016/j.crohns.2014.06.001
Publication status	Published - 2014
Externally published	Yes

Keywords

Ciprofloxacin
E. coli Nissle
Escherichia coli
Ulcerative colitis

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Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis : A double-blind randomized placebo controlled clinical trial. / Petersen, Andreas Munk; Mirsepasi, Hengameh; Halkjær, Sofie Ingdam et al.

In: Journal of Crohn's and Colitis, Vol. 8, No. 11, 2014, p. 1498-1505.

Research output: Contribution to journal › Journal article › Research › peer-review

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abstract = "Background and aim: Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC. Patients and methods: Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1. week followed by EcN or placebo for 7. weeks. All 4 treatments were given as add-on treatments. Results: One hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p. <. 0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p. <. 0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p. <. 0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively. Conclusions: Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.",

keywords = "Ciprofloxacin, E. coli Nissle, Escherichia coli, Ulcerative colitis",

author = "Petersen, {Andreas Munk} and Hengameh Mirsepasi and Halkj{\ae}r, {Sofie Ingdam} and Mortensen, {Esben Munk} and Inge Nordgaard-Lassen and Krogfelt, {Karen Angeliki}",

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T1 - Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis

T2 - A double-blind randomized placebo controlled clinical trial

AU - Petersen, Andreas Munk

AU - Mirsepasi, Hengameh

AU - Halkjær, Sofie Ingdam

AU - Mortensen, Esben Munk

AU - Nordgaard-Lassen, Inge

AU - Krogfelt, Karen Angeliki

PY - 2014

Y1 - 2014

N2 - Background and aim: Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC. Patients and methods: Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1. week followed by EcN or placebo for 7. weeks. All 4 treatments were given as add-on treatments. Results: One hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p. <. 0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p. <. 0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p. <. 0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively. Conclusions: Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.

AB - Background and aim: Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC. Patients and methods: Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1. week followed by EcN or placebo for 7. weeks. All 4 treatments were given as add-on treatments. Results: One hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p. <. 0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p. <. 0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p. <. 0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively. Conclusions: Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.

KW - Ciprofloxacin

KW - E. coli Nissle

KW - Escherichia coli

KW - Ulcerative colitis

U2 - 10.1016/j.crohns.2014.06.001

DO - 10.1016/j.crohns.2014.06.001

M3 - Journal article

C2 - 24972748

AN - SCOPUS:84927799957

SN - 1873-9946

VL - 8

SP - 1498

EP - 1505

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

IS - 11

ER -

Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis: A double-blind randomized placebo controlled clinical trial

Abstract

Keywords

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