Clinical trial NCT05867550: To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea
Official title: To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Irritable Bowel Syndrome
Diarrhea
IBS-D
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial in which participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.

* Participants of Group A will receive drug combination of Rifaximin and Mebeverine
* Participants of Group B will receive drug combination of Rifaximin and Amitriptyline
* Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk
* Each group will be given a combination of drugs for 2 weeks

Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention

At the end of study period , efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Primary purpose: TREATMENT

Brief 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

Detailed description: The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) 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?

Total of 162 Participants will be enrolled in study.

* Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.
* Participants of Group A will receive drug combination of Rifaximin and Mebeverine
* Participants of Group B will receive drug combination of Rifaximin and Amitriptyline
* Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk
* Each group will be given a combination of drugs for 2 weeks

Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention

Data will be collected using Questionnaire. Questionnaire will be filled by the researcher

SPSS will be used for analysis of data and appropriate test like Chi square Test, Student T test and One way ANOVA will be used to draw conclusions about the efficacy of different drug combinations and their potential side effects between the treatment groups

Eligibility criteria: Inclusion Criteria:

Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea

Exclusion Criteria:

* Presence of co morbid diseases
* Coronary Artery Disease (CAD)
* Chronic Obstructive Pulmonary Disease (COPD)
* Congestive Heart Failure (CHF)
* Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.)
* Patients having hyperthyroidism \& gluten hypersensitivity
* Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past
* Patients with recent change in bowel habits, patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility and malignancy of any other organ
* Patients with Irritable Bowel Disease and Celiac disease

Primary outcomes:
measure: Overall Improvement in Frequency of Diarrhea
timeFrame: 2 Weeks
measure: Overall Improvement in Characteristic of Diarrhea
timeFrame: 2 Weeks
measure: Overall Improvement in Abdominal Pain
timeFrame: 2 Weeks
measure: Compare Efficacy of Treatment Regimes in Treatment Groups
timeFrame: 4 Weeks
Secondary outcomes:
measure: To observe adverse effects of treatment regimes
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Bahria University Health Sciences Campus
state: Sindh
Study officials:
affiliation: Bahria University Health Science Campus Karachi
name: Rashid Ali
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.