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

NCT05867550 | Completed Phase 4 DMC

• 1 other identifier: ERC 106/2022
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

Irritable Bowel Syndrome; Diarrhea; IBS-D

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Overall Improvement in Abdominal Pain

  The study will assess change in abdominal pain from day 0 to day 14

  2 Weeks

• 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 Outcomes (1)

• To observe adverse effects of treatment regimes

  2 Weeks

Study Arms (3)

Group A ( Rifaximin + Mebeverine )

ACTIVE COMPARATOR

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks

Drug: Rifaximin 550 MG; Drug: Mebeverine 135 MG

Group B ( Rifaximin + Amitriptyline )

ACTIVE COMPARATOR

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks

Drug: Rifaximin 550 MG; Drug: Amitriptyline Hydrochloride 25 MG

Group C ( Rifaximin + Psyllium Husk )

ACTIVE COMPARATOR

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks

Drug: Rifaximin 550 MG; Drug: Psyllium Husk

Interventions

Rifaximin 550 MG DRUG

Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C

Also known as: Rifaxa 550MG, Nimixa 550 MG, Xifaxa 550MG, Zerifax 550MG, Nixaf 550 MG

Group A ( Rifaximin + Mebeverine ); Group B ( Rifaximin + Amitriptyline ); Group C ( Rifaximin + Psyllium Husk )

Mebeverine 135 MG DRUG

Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes

Also known as: Colofac 135 MG, Spasler Neo 135 MG, Mebever 135 MG

Group A ( Rifaximin + Mebeverine )

Psyllium Husk DRUG

Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes

Also known as: Ispaghol

Group C ( Rifaximin + Psyllium Husk )

Amitriptyline Hydrochloride 25 MG DRUG

Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

Also known as: Tryptanol 25 MG

Group B ( Rifaximin + Amitriptyline )

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Bahria University Health Sciences Campus

Karachi, Sindh, Pakistan

Location

Related 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.

  PMID: 28367168 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.

  PMID: 33946961 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.

  PMID: 30400292 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.

  PMID: 33564537 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.

  PMID: 27862281 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.

  PMID: 30460770 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Interventions

Rifaximin; mebeverine; Psyllium; Amitriptyline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rashid Ali

  Bahria University Health Science Campus Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 22, 2023
• Study Start: January 3, 2023
• Primary Completion: March 27, 2023
• Study Completion: June 10, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD data will be available 01 year after publication and will be available perpetually
• Access Criteria: All the data will be assessable to all

Locations

PA (1)