Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation

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

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.

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
    Egypt

    Active - Recruiting

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