Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: A randomized, double-blind, placebo-controlled, multicenter, phase II trial

C. H. Choi, J. G. Kwon, S. K. Kim, S. J. Myung, K. S. Park, C. I. Sohn, P. L. Rhee, K. J. Lee, O. Y. Lee, H. K. Jung, S. R. Jee, Yoon Tae Jeen, M. G. Choi, S. C. Choi, K. C. Huh, H. Park

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Probiotics can be beneficial in irritable bowel syndrome (IBS). Mosapride citrate, a selective 5-HT4 receptor agonist, stimulates gastrointestinal motility. We investigated the efficacy of combination therapy with probiotics and mosapride for non-diarrheal-type IBS. Methods: Two hundred and eighty-five IBS patients were randomly assigned to either a combination of probiotics (Bacillus subtilis and Streptococcus faecium) and mosapride at one of four different doses or a placebo for 4 weeks. The primary outcome was the proportion of patients experiencing adequate relief (AR) of global IBS symptoms at week 4. The secondary outcomes included subject's global assessment (SGA) of IBS symptom relief, individual symptoms, stool parameters, and IBS-quality of life. Key Results: The proportion of AR at week 4 was significantly higher in all treatment groups compared to the placebo group (53.7% in group 1, 55.0% in group 2, 55.2% in group 3, 53.6% in group 4 [the highest dose], and 35.1% in placebo group, respectively, p < 0.05). The proportion of patients reporting 'completely or considerably relieved' in the SGA was higher in the treatment groups than in the placebo group. The abdominal pain/discomfort score in the treatment group 4 was more prominently improved compared with that of the placebo group. In patients with constipation-predominant IBS, the improvements in stool frequency and consistency were significantly higher in the treatment groups 4 and 1, respectively, than those in the placebo group. Conclusions & Inferences: Combination therapy with probiotics and mosapride is effective for relief of symptoms in patients with non-diarrheal-type IBS. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT01505777).

Original languageEnglish
Pages (from-to)705-716
Number of pages12
JournalNeurogastroenterology and Motility
Volume27
Issue number5
DOIs
Publication statusPublished - 2015 May 1

Fingerprint

Irritable Bowel Syndrome
Probiotics
Diarrhea
Placebos
Therapeutics
Serotonin 5-HT4 Receptor Agonists
Receptors, Serotonin, 5-HT4
National Library of Medicine (U.S.)
Enterococcus faecium
Gastrointestinal Motility
mosapride
Constipation
Bacillus subtilis
Abdominal Pain
Quality of Life

Keywords

  • Irritable bowel syndrome
  • Mosapride
  • Probiotics

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

Cite this

Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea : A randomized, double-blind, placebo-controlled, multicenter, phase II trial. / Choi, C. H.; Kwon, J. G.; Kim, S. K.; Myung, S. J.; Park, K. S.; Sohn, C. I.; Rhee, P. L.; Lee, K. J.; Lee, O. Y.; Jung, H. K.; Jee, S. R.; Jeen, Yoon Tae; Choi, M. G.; Choi, S. C.; Huh, K. C.; Park, H.

In: Neurogastroenterology and Motility, Vol. 27, No. 5, 01.05.2015, p. 705-716.

Research output: Contribution to journalArticle

Choi, CH, Kwon, JG, Kim, SK, Myung, SJ, Park, KS, Sohn, CI, Rhee, PL, Lee, KJ, Lee, OY, Jung, HK, Jee, SR, Jeen, YT, Choi, MG, Choi, SC, Huh, KC & Park, H 2015, 'Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: A randomized, double-blind, placebo-controlled, multicenter, phase II trial', Neurogastroenterology and Motility, vol. 27, no. 5, pp. 705-716. https://doi.org/10.1111/nmo.12544
Choi, C. H. ; Kwon, J. G. ; Kim, S. K. ; Myung, S. J. ; Park, K. S. ; Sohn, C. I. ; Rhee, P. L. ; Lee, K. J. ; Lee, O. Y. ; Jung, H. K. ; Jee, S. R. ; Jeen, Yoon Tae ; Choi, M. G. ; Choi, S. C. ; Huh, K. C. ; Park, H. / Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea : A randomized, double-blind, placebo-controlled, multicenter, phase II trial. In: Neurogastroenterology and Motility. 2015 ; Vol. 27, No. 5. pp. 705-716.
@article{a90d3d33c578461b9a107cf3f0fb06e9,
title = "Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: A randomized, double-blind, placebo-controlled, multicenter, phase II trial",
abstract = "Background: Probiotics can be beneficial in irritable bowel syndrome (IBS). Mosapride citrate, a selective 5-HT4 receptor agonist, stimulates gastrointestinal motility. We investigated the efficacy of combination therapy with probiotics and mosapride for non-diarrheal-type IBS. Methods: Two hundred and eighty-five IBS patients were randomly assigned to either a combination of probiotics (Bacillus subtilis and Streptococcus faecium) and mosapride at one of four different doses or a placebo for 4 weeks. The primary outcome was the proportion of patients experiencing adequate relief (AR) of global IBS symptoms at week 4. The secondary outcomes included subject's global assessment (SGA) of IBS symptom relief, individual symptoms, stool parameters, and IBS-quality of life. Key Results: The proportion of AR at week 4 was significantly higher in all treatment groups compared to the placebo group (53.7{\%} in group 1, 55.0{\%} in group 2, 55.2{\%} in group 3, 53.6{\%} in group 4 [the highest dose], and 35.1{\%} in placebo group, respectively, p < 0.05). The proportion of patients reporting 'completely or considerably relieved' in the SGA was higher in the treatment groups than in the placebo group. The abdominal pain/discomfort score in the treatment group 4 was more prominently improved compared with that of the placebo group. In patients with constipation-predominant IBS, the improvements in stool frequency and consistency were significantly higher in the treatment groups 4 and 1, respectively, than those in the placebo group. Conclusions & Inferences: Combination therapy with probiotics and mosapride is effective for relief of symptoms in patients with non-diarrheal-type IBS. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT01505777).",
keywords = "Irritable bowel syndrome, Mosapride, Probiotics",
author = "Choi, {C. H.} and Kwon, {J. G.} and Kim, {S. K.} and Myung, {S. J.} and Park, {K. S.} and Sohn, {C. I.} and Rhee, {P. L.} and Lee, {K. J.} and Lee, {O. Y.} and Jung, {H. K.} and Jee, {S. R.} and Jeen, {Yoon Tae} and Choi, {M. G.} and Choi, {S. C.} and Huh, {K. C.} and H. Park",
year = "2015",
month = "5",
day = "1",
doi = "10.1111/nmo.12544",
language = "English",
volume = "27",
pages = "705--716",
journal = "Neurogastroenterology and Motility",
issn = "1350-1925",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea

T2 - A randomized, double-blind, placebo-controlled, multicenter, phase II trial

AU - Choi, C. H.

AU - Kwon, J. G.

AU - Kim, S. K.

AU - Myung, S. J.

AU - Park, K. S.

AU - Sohn, C. I.

AU - Rhee, P. L.

AU - Lee, K. J.

AU - Lee, O. Y.

AU - Jung, H. K.

AU - Jee, S. R.

AU - Jeen, Yoon Tae

AU - Choi, M. G.

AU - Choi, S. C.

AU - Huh, K. C.

AU - Park, H.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background: Probiotics can be beneficial in irritable bowel syndrome (IBS). Mosapride citrate, a selective 5-HT4 receptor agonist, stimulates gastrointestinal motility. We investigated the efficacy of combination therapy with probiotics and mosapride for non-diarrheal-type IBS. Methods: Two hundred and eighty-five IBS patients were randomly assigned to either a combination of probiotics (Bacillus subtilis and Streptococcus faecium) and mosapride at one of four different doses or a placebo for 4 weeks. The primary outcome was the proportion of patients experiencing adequate relief (AR) of global IBS symptoms at week 4. The secondary outcomes included subject's global assessment (SGA) of IBS symptom relief, individual symptoms, stool parameters, and IBS-quality of life. Key Results: The proportion of AR at week 4 was significantly higher in all treatment groups compared to the placebo group (53.7% in group 1, 55.0% in group 2, 55.2% in group 3, 53.6% in group 4 [the highest dose], and 35.1% in placebo group, respectively, p < 0.05). The proportion of patients reporting 'completely or considerably relieved' in the SGA was higher in the treatment groups than in the placebo group. The abdominal pain/discomfort score in the treatment group 4 was more prominently improved compared with that of the placebo group. In patients with constipation-predominant IBS, the improvements in stool frequency and consistency were significantly higher in the treatment groups 4 and 1, respectively, than those in the placebo group. Conclusions & Inferences: Combination therapy with probiotics and mosapride is effective for relief of symptoms in patients with non-diarrheal-type IBS. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT01505777).

AB - Background: Probiotics can be beneficial in irritable bowel syndrome (IBS). Mosapride citrate, a selective 5-HT4 receptor agonist, stimulates gastrointestinal motility. We investigated the efficacy of combination therapy with probiotics and mosapride for non-diarrheal-type IBS. Methods: Two hundred and eighty-five IBS patients were randomly assigned to either a combination of probiotics (Bacillus subtilis and Streptococcus faecium) and mosapride at one of four different doses or a placebo for 4 weeks. The primary outcome was the proportion of patients experiencing adequate relief (AR) of global IBS symptoms at week 4. The secondary outcomes included subject's global assessment (SGA) of IBS symptom relief, individual symptoms, stool parameters, and IBS-quality of life. Key Results: The proportion of AR at week 4 was significantly higher in all treatment groups compared to the placebo group (53.7% in group 1, 55.0% in group 2, 55.2% in group 3, 53.6% in group 4 [the highest dose], and 35.1% in placebo group, respectively, p < 0.05). The proportion of patients reporting 'completely or considerably relieved' in the SGA was higher in the treatment groups than in the placebo group. The abdominal pain/discomfort score in the treatment group 4 was more prominently improved compared with that of the placebo group. In patients with constipation-predominant IBS, the improvements in stool frequency and consistency were significantly higher in the treatment groups 4 and 1, respectively, than those in the placebo group. Conclusions & Inferences: Combination therapy with probiotics and mosapride is effective for relief of symptoms in patients with non-diarrheal-type IBS. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT01505777).

KW - Irritable bowel syndrome

KW - Mosapride

KW - Probiotics

UR - http://www.scopus.com/inward/record.url?scp=84928195784&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84928195784&partnerID=8YFLogxK

U2 - 10.1111/nmo.12544

DO - 10.1111/nmo.12544

M3 - Article

C2 - 25809913

AN - SCOPUS:84928195784

VL - 27

SP - 705

EP - 716

JO - Neurogastroenterology and Motility

JF - Neurogastroenterology and Motility

SN - 1350-1925

IS - 5

ER -