Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double‐blind, placebo‐controlled, multicenter, phase II trial
Open accessAbstract
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).
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A combination of probiotics Bacillus subtilis and Streptococcus faecium was effective for relief of symptoms in patients with non-diarrheal-type IBS.
“a combination of probiotics (Bacillus subtilis and Streptococcus faecium) was effective for relief of symptoms in patients with non diarrhealtype IBS [212]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [212]
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Gut microbiota role in irritable bowel syndrome: New therapeutic strategies
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- Authors
- Choi, C. H., Kwon, J. G., Kim, S. K., Myung, S. ‐., Park, K. S., Sohn, C. ‐., Rhee, P. ‐., Lee, K. J., Lee, O. Y., Jung, H. ‐., Jee, S. R., Jeen, Y. T., Choi, M. ‐., Choi, S. C., Huh, K. C., & Park, H.
- Affiliations
- Chung-Ang University Hospital (KR)
- Daegu Catholic University (KR)
- Kyungpook National University (KR)
- University of Ulsan (KR)
- Keimyung University (KR)
- Sungkyunkwan University (KR)
- Ajou University (KR)
- Hanyang University (KR)
- Ewha Womans University (KR)
- Inje University (KR)
- Korea University (KR)
- Catholic University of Korea (KR)
- Wonkwang University (KR)
- Konyang University (KR)
- Yonsei University (KR)
- Corresponding author
- Park, H.
- ORCID
- Venue
- Neurogastroenterology & Motility
- Publisher
- Wiley
- Published
- 2015-03-25
- Volume
- 27
- Issue
- 5
- Pages
- 705-716
- ISSN
- 1350-1925 (ISSN-L)
- 1365-2982
- OpenAlex
- W2144598479
- Cited by
- 46
- References
- 53
- Citations by year
- 2025: 6 · 2024: 6 · 2023: 5 · 2022: 3 · 2021: 6 · 2020: 4 · 2019: 3 · 2018: 2 · 2017: 4 · 2016: 4 · 2015: 1 · 2014: 1
- FWCI
- 3.82
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Neurogastroenterology & Motility (publishedVersion)
- PubMed (publishedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- AJOU Open Repository (Ajou University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, mosapride, Bacillus subtilis, Enterococcus faecium, 5-HT4 receptor agonist, combination therapy, gastrointestinal motility, abdominal pain, IBS quality of life
- MeSH terms
- Adult, Bacillus subtilis, Benzamides, Double-Blind Method, Drug Therapy, Combination, Female, Gastrointestinal Agents, Gastrointestinal Motility, Humans, Male, Middle Aged, Morpholines, Quality of Life, Abdominal Pain, Treatment Outcome, Enterococcus faecium, Probiotics, Irritable Bowel Syndrome
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