Last updated: November 20, 2023
Sponsor: Sadat City University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Constipation
Colic
Hyponatremia
Treatment
Nitazoxanide 500Mg Oral Tablet
Rifaximin 550Mg Tab
Clinical Study ID
NCT05453916
202207MH1
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) abdominalpain score of > 3.0 on a 0-to-10-point scale and Stool Consistency: at least one stoolwith a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 daysper week
- Report no restriction whatsoever on their diet.
Exclusion
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/orcholecystectomy and/or hysterectomy.
- Patients who consumed any medications that may affect bowel function within the last 2weeks 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 weeksbefore eligibility check.
Study Design
Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Nitazoxanide 500Mg Oral Tablet
Phase: 1/2
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2024
Connect with a study center
Faculty of Pharmacy, University of Sadat city
Sadat City, Menoufia 13829
EgyptActive - Recruiting
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