Back to resultsComparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Primary Purpose
Irritable Bowel Syndrome With Diarrhea
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide 500Mg Oral Tablet
Rifaximin 550Mg Tab
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea
Eligibility Criteria
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.
Sites / Locations
- Faculty of Pharmacy, University of Sadat cityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nitazoxanide
Rifaximin
Arm Description
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05453916
Brief Title
Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Official Title
A Randomized Single-Blind Controlled Trial Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Experimental
Arm Description
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Arm Title
Rifaximin
Arm Type
Active Comparator
Arm Description
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide 500Mg Oral Tablet
Intervention Description
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Rifaximin 550Mg Tab
Intervention Description
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Biological markers
Description
The serological outcomes included the variation in interleukin-6 and anti-cdtB levels
Time Frame
6 weeks - 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Pharmacy, University of Sadat city
City
Sadat City
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed Elmowafy, BSc.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
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