drugset / Trial / NCT05867550
To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is: * Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea? Participants will be divided into 3 treatment groups. * Each group will be given a combination of drugs for 2 weeks * At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Timeline
- Start
- 2023-01-03
- Primary completion
- 2023-03-27
- Completion
- 2023-06-10
Publications
- Background Alaqeel MK, Alowaimer NA, Alonezan AF, Almegbel NY, Alaujan FY. Prevalence of Irritable Bowel Syndrome and its Association with Anxiety among Medical Students at King Saud bin Abdulaziz University for Health Sciences in Riyadh. Pak J Med Sci. 2017 Jan-Feb;33(1):33-36. doi: 10.12669/pjms.331.12572.
- Background Altomare A, Di Rosa C, Imperia E, Emerenziani S, Cicala M, Guarino MPL. Diarrhea Predominant-Irritable Bowel Syndrome (IBS-D): Effects of Different Nutritional Patterns on Intestinal Dysbiosis and Symptoms. Nutrients. 2021 Apr 29;13(5):1506. doi: 10.3390/nu13051506.
- Background Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650.
- Background Bachani P, Kumar L, Kumar N, Fatima M, Naz S, Memon MK, Memon S, Rizwan A. Prevalence of Irritable Bowel Syndrome and Frequency of Symptoms in the General Population of Pakistan. Cureus. 2021 Jan 6;13(1):e12541. doi: 10.7759/cureus.12541.
- Background Bai T, Xia J, Jiang Y, Cao H, Zhao Y, Zhang L, Wang H, Song J, Hou X. Comparison of the Rome IV and Rome III criteria for IBS diagnosis: A cross-sectional survey. J Gastroenterol Hepatol. 2017 May;32(5):1018-1025. doi: 10.1111/jgh.13642.
- Background Barbara G, Cremon C, Azpiroz F. Probiotics in irritable bowel syndrome: Where are we? Neurogastroenterol Motil. 2018 Dec;30(12):e13513. doi: 10.1111/nmo.13513.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amitriptyline | Small molecule | 25 mg | Oral |
| Comparator | Mebeverine | Small molecule | 135 mg | Oral |
| Comparator | Psyllium husk | Unknown | 15 mg | Oral |
| Comparator | Psyllium husk | Unknown | 35 mg | Oral |
| Comparator | Rifaximin | Other / unclassified | 550 mg | Oral |