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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453916
• Other study ID #: 202207MH1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nitazoxanide 500Mg Oral Tablet
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
• Rifaximin 550Mg Tab
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, University of Sadat city	Sadat City	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biological markers	The serological outcomes included the variation in interleukin-6 and anti-cdtB levels	6 weeks - 12 weeks
Primary	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	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