CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Rifaximin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04557215
NCT04557215Phase 2Completed
CompareCT.gov

Evaluation of the Efficacy and Safety of Rifaximin in Combination With N-acetylcysteine (NAC) in Adult Patients With Irritable Bowel Syndrome With Diarrhea

Cedars-Sinai Medical Center·interventional·Posted Sep 21, 2020·Updated Mar 28, 2023

In Brief

A Phase 2 clinical trial evaluating Rifaximin, N-acetylcysteine, and 1 other intervention for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 45 participants across 1 site.

Detailed Summary

Randomized, prospective proof of concept, double-blind, single site clinical trial to determine the efficacy of combined rifaximin and N-acetylcysteine (NAC) therapy vs. rifaximin alone in decreasing clinical symptoms in subjects with IBS-D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesUnited States
CollaboratorsBausch Health Ireland Limited

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 21, 2020
Enrollment StartNov 13, 2020
Primary CompletionAug 31, 2021
Study CompletionOct 30, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.8 years ago

Interventions

Rifaximindrug

Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

N-acetylcysteinedrug

N-acetylcysteine (NAC) is a clinically approved mucolytic agent.

Placebodrug

An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.