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Tests treatment safety and results for IBS (Irritable Bowel Syndrome)
Official title Efficacy of Rifaximin With NAC in IBS-D
ClinicalTrials.gov ID: NCT06727422
What this study is testing
What is rifaximin 66mg + N-acetylcysteine 560mg three times daily?
rifaximin 66mg + N-acetylcysteine 560mg three times daily is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ibs (irritable bowel syndrome).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or non-pregnant, non-lactating female patients ≥ 18 years of age
- Diagnosed with IBS confirmed by the Rome IV criteria, with associated symptoms of diarrhea as noted below in 4(b).
- Do not have adequate relief of IBS symptoms of abdominal pain, stool consistency or stool frequency
- Have daily IBS symptom scores during screening as below:
- Weekly average score of worst daily abdominal pain \>3.0 on a 0-10 point scale
You likely can't join if
- Present with the following symptoms of IBS with constipation:
- Less than 3 bowel movements a week,
- Hard or lumpy stools, and
- Excessive straining during a bowel movement.
- History of inflammatory bowel disease, celiac disease, GI surgery (except cholecystectomy and/or appendectomy)
- Evidence of active duodenal ulcer, gastric ulcer, diverticulitis, or active infectious gastroenteritis
See the full eligibility criteria
- Male or non-pregnant, non-lactating female patients ≥ 18 years of age
- Diagnosed with IBS confirmed by the Rome IV criteria, with associated symptoms of diarrhea as noted below in 4(b).
- Do not have adequate relief of IBS symptoms of abdominal pain, stool consistency or stool frequency
- Have daily IBS symptom scores during screening as below:
- Weekly average score of worst daily abdominal pain \>3.0 on a 0-10 point scale
- At least one stool with a consistency of Type 6 or 7 on the Bristol
- Present with the following symptoms of IBS with constipation:
- Less than 3 bowel movements a week,
- Hard or lumpy stools, and
- Excessive straining during a bowel movement.
- History of inflammatory bowel disease, celiac disease, GI surgery (except cholecystectomy and/or appendectomy)
- Evidence of active duodenal ulcer, gastric ulcer, diverticulitis, or active infectious gastroenteritis
- Current diagnosis of asthma
- Current user of NAC and/or rifaximin
- Systemic antibiotic use in the last month
- Not currently on a prokinetic drug
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.