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The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics(Medirac) 10/mosapride 10mg | Experimental |
| |
| Probiotics(Medirac) 15/mosapride 10mg | Experimental |
| |
| Probiotics(Medirac) 15/mosapride 15mg | Experimental |
| |
| Probiotics(Medirac) 30/mosapride 15mg | Experimental |
| |
| Probiotics(Medirac) placebo/mosapride placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics (Medirac) | Drug | 10/mosapride 10mg three times a day, P.O. 4week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms | baseline and 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks) | baseline and 4 weeks, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo Jin Park, M.D., Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 16 institutions including Gangnam Severance hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25809913 | Derived | 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. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Neurogastroenterol Motil. 2015 May;27(5):705-16. doi: 10.1111/nmo.12544. Epub 2015 Mar 25. |
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| Probiotics (Medirac) | Drug | 15/mosapride 10mg three times a day, P.O. 4week |
|
| Probiotics (Medirac) | Drug | 15/mosapride 15mg three times a day, P.O. 4week |
|
| Probiotics (Medirac) | Drug | 30/mosapride 15mg three times a day, P.O. 4week |
|
| Probiotics (Medirac) placebo/mosapride placebo | Drug | three times a day, P.O. 4week |
|
| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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