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

Phase 1

Recruiting

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Drug: Nitazoxanide 500Mg Oral Tablet; Drug: Rifaximin 550Mg Tab

• Registration Number: NCT05453916
• Lead Sponsor: Sadat City University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitazoxanide	Nitazoxanide 500Mg Oral Tablet	patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Rifaximin	Rifaximin 550Mg Tab	patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
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	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)

Trial Locations

Locations (1)

Faculty of Pharmacy, University of Sadat city; 🇪🇬 Sadat City, Menoufia, Egypt