Irritable Bowel Syndrome With Diarrhea
Conditions
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.
Interventions
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
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | 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) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biological markers | 6 weeks - 12 weeks | The serological outcomes included the variation in interleukin-6 and anti-cdtB levels |
Countries
Egypt
Outcome results
None listed