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

S

Sadat City University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Irritable Bowel Syndrome With Diarrhea

Treatments

Drug: Rifaximin 550Mg Tab
Drug: Nitazoxanide 500Mg Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05453916
202207MH1

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Nitazoxanide
Experimental group
Description:
patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days
Treatment:
Drug: Nitazoxanide 500Mg Oral Tablet
Rifaximin
Active Comparator group
Description:
patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.
Treatment:
Drug: Rifaximin 550Mg Tab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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