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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome With Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nitazoxanide

patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days

Group Type EXPERIMENTAL

Nitazoxanide 500Mg Oral Tablet

Intervention Type DRUG

patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days

Rifaximin

patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days.

Group Type ACTIVE_COMPARATOR

Rifaximin 550Mg Tab

Intervention Type DRUG

patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days

Interventions

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Nitazoxanide 500Mg Oral Tablet

patients receiving treatment with Nitazoxanide 500 mg two times daily for 14 days

Intervention Type DRUG

Rifaximin 550Mg Tab

patients receiving treatment rifaximin at a dose of 550 mg three times daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No