Comparing nitazoxanide and rifaximin for treating diarrhea in IBS patients
A Randomized Single-Blind Controlled Trial Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
PHASE1; PHASE2 · Sadat City University · NCT05453916
This study is testing whether nitazoxanide or rifaximin works better to help adults with irritable bowel syndrome who have diarrhea feel better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sadat City University (other) |
| Locations | 1 site (Sadat City, Menoufia) |
| Trial ID | NCT05453916 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of nitazoxanide versus rifaximin in treating diarrhea associated with irritable bowel syndrome (IBS) in adults. Participants will receive a 2-week course of either medication, followed by a 10-week evaluation period to assess the long-term efficacy in alleviating IBS symptoms. The study focuses on patients who meet specific criteria related to their IBS symptoms and dietary restrictions. By analyzing the outcomes, the research seeks to determine which treatment offers better relief for patients suffering from diarrhea-predominant IBS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with diarrhea-predominant IBS and have active symptoms.
Not a fit: Patients with liver disease, malignancies, severe malabsorption, or those on medications affecting bowel function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for managing diarrhea associated with IBS.
How similar studies have performed: While there have been studies on IBS treatments, this specific comparison of nitazoxanide and rifaximin is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sadat City, Menoufia
- Faculty of Pharmacy, University of Sadat city — Sadat City, Menoufia, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome With Diarrhea