To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05867550
• Other study ID #: ERC 106/2022
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: July 2023
• Source: Bahria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 10, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• Rifaximin 550 MG
Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C
• Mebeverine 135 MG
Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes
• Psyllium Husk
Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes
• Amitriptyline Hydrochloride 25 MG
Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

Locations

Country	Name	City	State
Pakistan	Bahria University Health Sciences Campus	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Bahria University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Improvement in Frequency of Diarrhea	The study will assess change in number of stools per day from day 0 to day 14	2 Weeks
Primary	Overall Improvement in Characteristic of Diarrhea	The study will assess change in characteristic of stool type from type 6,7 to 4 according to Bristol Stool Chart from day 0 to day 14	2 Weeks
Primary	Overall Improvement in Abdominal Pain	The study will assess change in abdominal pain from day 0 to day 14	2 Weeks
Primary	Compare Efficacy of Treatment Regimes in Treatment Groups	The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups	4 Weeks
Secondary	To observe adverse effects of treatment regimes	The study will observe number of participants with adverse effects like Nausea, Stomachache, Dizziness, Tiredness, Joint Pain, Headache, Heartburn, Constipation, Dry Mouth, Sedation and Bloating of drugs in different groups and compare them	2 Weeks