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

NCT05453916 | Withdrawn Phase 1 DMC

• 1 other identifier: 202207MH1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• Biological markers

  6 weeks - 12 weeks

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days

Drug: Nitazoxanide 500Mg Oral Tablet

Rifaximin

ACTIVE COMPARATOR

patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.

Drug: Rifaximin 550Mg Tab

Interventions

Nitazoxanide 500Mg Oral Tablet DRUG

patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days

Nitazoxanide

Rifaximin 550Mg Tab DRUG

patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days

Rifaximin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy, University of Sadat city

Madīnat as Sādāt, Menoufia, 13829, Egypt

Location

MeSH Terms

Interventions

nitazoxanide; Tablets; Rifaximin

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

EG (1)