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Efficacy and Safety of Rifaximin With NAC in IBS-D

NCT04557215 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-03-28

Study results available
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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.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

Rifaximin

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

DRUG

N-acetylcysteine

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

DRUG

Placebo

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.

Sponsors & Collaborators

  • Bausch Health Ireland Limited

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Mark Pimentel, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-08-31
Completion
2022-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557215 on ClinicalTrials.gov