IBS study: Rifaximin vs RNIB21 containing rifaximin
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?
an investigational oral combination being studied as a potential treatment for irritable bowel syndrome with diarrhea (IBS-D) rifaximin is designed to stay in the gastrointestinal tract and reduce bacterial overgrowth, while N-acetylcysteine is designed to act as an antioxidant and help thin mucus
Also referred to as rifaximin; N-acetylcysteine (NAC).
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 study wants to see whether the combination of rifaximin and NAC reduces IBS‑D symptoms more than rifaximin alone.
- Who it's for
- Adults who have been diagnosed with diarrhea‑predominant irritable bowel syndrome.
- What's involved
- Participants will take rifaximin (550 mg three times daily) for 14 days together with NAC supplement capsules (two different doses are being tested) and will attend study visits for assessments and safety checks.
- Time commitment
- The medication period is about two weeks, with a few clinic visits during and after treatment for follow‑up.
- 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
- 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
You likely can't join if
- 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
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
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.