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- 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.
- Authors
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, Y. T.; Choi, M.‐G.; Choi, S. C.; Huh, K. C.; Park, H.
- 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 (, NCT01505777).
- Subjects
PROBIOTICS; RANDOMIZED controlled trials; IRRITABLE colon; GASTROINTESTINAL diseases; BACILLUS subtilis; ENTEROCOCCUS faecium; PLACEBOS
- Publication
Neurogastroenterology & Motility, 2015, Vol 27, Issue 5, p705
- ISSN
1350-1925
- Publication type
Article
- DOI
10.1111/nmo.12544