A Randomized Single-Blind Controlled Trial Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nitazoxanide
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Intervention: Nitazoxanide 500Mg Oral Tablet (Drug)
Rifaximin
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.
Intervention: Rifaximin 550Mg Tab (Drug)
Outcomes
Primary Outcomes
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period
Time Frame: 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 Outcomes
- 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)
Investigators
Mahmoud Samy Abdallah
Principle Investigator
Sadat City University