Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation

A Randomized Single-Blind Controlled Trial Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation

This study aim to compare the efficacy of nitazoxanide in 2-week course of treatment with rifaximin in treating diarrhea associated with IBS. We also aim to study its effect over 10 weeks after treatment to evaluate its efficacy in eradicating symptoms of IBS in the long run.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Drug: Nitazoxanide 500Mg Oral Tablet; Drug: Rifaximin 550Mg Tab

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Sadat City, Menoufia, Egypt, 13829
      • Recruiting
      • Faculty of Pharmacy, University of Sadat city
      • Principal Investigator: Mohamed Elmowafy, BSc.
      • Contact: Mahmoud S Abdallah, PhD; Phone Number: 01063340887; Email: Mahmoud.samy@fop.usc.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 years of age or older.
• Patients suffering from diarrhea-predominant IBS according to Rome III criteria.
• Active symptoms for at least 2 weeks
• Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0-to-10-point scale and Stool Consistency: at least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week
• Report no restriction whatsoever on their diet.

Exclusion Criteria:

• Presence of liver disease, malignancy, severe malabsorption, bedridden, endocrinological disorders, or severe chronic obstructive pulmonary disease.
• Patients who have undergone abdominal surgeries except for appendectomy and/or cholecystectomy and/or hysterectomy.
• Patients who consumed any medications that may affect bowel function within the last 2 weeks such as antibiotics, probiotics, prebiotics, antispasmodics, antidiarrheals, narcotics, or any other medication that may alter bowel function
• Patients on antidepressants or antipsychotics starting within the last six weeks before eligibility check.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitazoxanide; patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days	Drug: Nitazoxanide 500Mg Oral Tablet; patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Active Comparator: Rifaximin; patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.	Drug: Rifaximin 550Mg Tab; patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period	The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)	Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological markers	The serological outcomes included the variation in interleukin-6 and anti-cdtB levels	6 weeks - 12 weeks

Collaborators and Investigators

• Sponsor: Sadat City University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Constipation; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Antiparasitic Agents; Rifaximin; Nitazoxanide
• Other Study ID Numbers: 202207MH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No