Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06727422

Efficacy of Rifaximin With NAC in IBS-D

Led by Mark Pimentel, MD · Updated on 2026-04-20

225

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patients find that their symptoms may not completely resolve, or may come back after a period of time. This research study is designed to test the investigational use of a combination of rifaximin and NAC. The combination of rifaximin and NAC is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS-D, and the effects of taking both medications together are unknown. However, the two medications are approved for use separately, as detailed below. Rifaximin is the only antibiotic approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 550 mg by mouth three times daily for 14 days) is approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 200 mg per mouth three times daily for 3 days) is FDA approved for the treatment of traveler's diarrhea. Rifaximin at a dose of 200 mg per mouth three times daily is not approved by the FDA for the treatment of IBS-D. NAC is approved by the FDA to treat acetaminophen overdose (72-hour oral and 21-hour intravenous (IV) regimens), and for use in breaking up mucus in the lungs in patients with chronic obstructive pulmonary disease (COPD) and other lung conditions such as bronchitis. NAC is also available over-the-counter in 600 mg and 900 mg capsules as a dietary supplement, although over-the-counter use is not regulated by the FDA. This study will utilize the 600 mg dietary supplement capsules. The Investigators want to know if using a combination of rifaximin and NAC will give better results in decreasing IBS-D symptoms than using rifaximin alone. As NAC is used to break up mucus in the lungs, and the Investigators want to see if this can also break up the mucus layer in the small intestine, and therefore potentially increase the effectiveness of rifaximin. The Investigators will be testing 2 doses to determine which dose is most effective. participants are being asked to take part in this research study because participants were diagnosed with IBS-D.

CONDITIONS

Official Title

Efficacy of Rifaximin With NAC in IBS-D

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant, non-lactating female patients 18 years of age or older
  • Diagnosed with IBS confirmed by Rome IV criteria with diarrhea symptoms
  • Lack adequate relief of abdominal pain, stool consistency, or stool frequency related to IBS
  • Have weekly average worst abdominal pain score greater than 3 on a 0-10 scale during screening
  • Have at least one stool with type 6 or 7 consistency on the Bristol Stool Scale during screening
Not Eligible

You will not qualify if you...

  • Symptoms of IBS with constipation including less than 3 bowel movements per week, hard or lumpy stools, and excessive straining
  • History of inflammatory bowel disease, celiac disease, or gastrointestinal surgery except cholecystectomy or appendectomy
  • Active duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis
  • Current diagnosis of asthma
  • Current use of NAC and/or rifaximin
  • Use of systemic antibiotics in the last month
  • Not currently taking a prokinetic drug
  • Significant medical conditions including hepatic, uncontrolled diabetes, renal, cardiovascular, pulmonary, uncontrolled thyroid, or psychiatric diseases that preclude participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

M

Mark Pimentel, MD

CONTACT

A

Ava Hosseini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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