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Efficacy of Rifaximin With NAC in IBS-D

RecruitingPhase 2Ages 18 Years - anyAllMark Pimentel, MD
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In plain words

What the trial is, and whether it could suit you

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 antibi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female patients โ‰ฅ 18 years of age 2. Diagnosed with IBS confirmed by the Rome IV criteria, with associated symptoms of diarrhea as noted below in 4(b). 3. Do not have adequate relief of IBS symptoms of abdominal pain, stool consistency or stool frequency 4. Have daily IBS symptom scores during screening as below: 1. Weekly average score of worst daily abdominal pain \>3.0 on a 0-10 point scale 2. At least one stool with a consistency of Type 6 or 7 on the Bristol Exclusion Criteria: 1. Present with the following symptoms of IBS with constipation: 1. Less than 3 bowel movements a week, 2. Hard or lumpy stools, and 3. Excessive straining during a bowel movement. 2. History of inflammatory bowel disease, celiac disease, GI surgery (except cholecystectomy and/or appendectomy) 3. Evidence of active duodenal ulcer, gastric ulcer, diverticulitis, or active infectious gastroenteritis 4. Current diagnosis of asthma 5. Current user of NAC and/or rifaximin 6. Systemic antibiotic use in the last month 7. Not currently on a prokinetic drug 8. A significant medical condition including but not limited to hepatic, uncontrolled diabetes, renal, cardiovascular, pulmonary, uncontrolled thyroid disease. or psychiatric disease, which in the opinion of investigator precludes study participation
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What it tests

  • rifaximin 66mg + N-acetylcysteine 560mg three times daily
  • RNIB21 containing rifaximin 132mg + N-acetylcysteine 560mg three times daily
  • Placebo
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Where

1 site
Cedars-Sinai Medical Center
Los Angeles, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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