Rifaximin + NAC for IBS-D
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining rifaximin, a standard IBS-D treatment, with NAC, a dietary supplement, can better relieve symptoms of irritable bowel syndrome with diarrhea (IBS-D) than rifaximin alone. Researchers are testing two different doses of this combination to identify the most effective one. Individuals diagnosed with IBS-D who continue to experience frequent diarrhea, abdominal pain, or inconsistent stools might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rifaximin is generally safe and effective for treating irritable bowel syndrome with diarrhea (IBS-D). The FDA has approved it for this use. However, it benefits only about 44% of patients, so it does not work for everyone. Rifaximin has been used multiple times without major safety issues.
N-acetyl-L-cysteine (NAC) is also considered safe. The FDA has approved it for certain lung conditions, and it is available over-the-counter as a dietary supplement. While researchers are still studying the combination of rifaximin and NAC for IBS-D, both are known to be safe when used individually.
This study is in an early stage, focusing on the safety and effectiveness of this combination. Current evidence suggests that using rifaximin with NAC might improve treatment for some patients. However, the specific effects and safety of using them together for IBS-D remain under investigation.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for IBS-D because they combine rifaximin, an antibiotic, with N-acetylcysteine (NAC), an antioxidant. This pairing is unique because while standard treatments often focus solely on gut bacteria or inflammation, this duo targets both. The potential synergy between rifaximin's ability to adjust gut bacteria and NAC's antioxidant properties might offer more comprehensive relief. Plus, the trial explores both low and high doses of rifaximin, providing insights into optimizing dosage for better patient outcomes.
What evidence suggests that this trial's treatments could be effective for IBS-D?
This trial will evaluate the effectiveness of combining rifaximin with N-acetylcysteine (NAC) for IBS-D. Studies have shown that rifaximin effectively relieves symptoms like stomach pain and diarrhea in IBS-D patients. However, not everyone experiences complete relief, and symptoms might return over time. In this trial, participants will receive either a low or high dose of rifaximin combined with NAC, or a placebo. Research suggests that combining rifaximin with NAC could enhance results for IBS-D patients. NAC, known for clearing mucus in the lungs, might also clear mucus in the intestines, allowing rifaximin to work more effectively. Early findings indicate that adding NAC to rifaximin may increase the number of patients who respond well to the treatment.12456
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RNIB21 containing rifaximin and NAC or placebo for 14 days
Primary Evaluation Period
Participants are monitored for adequate relief of IBS symptoms based on abdominal pain and stool consistency
Follow-up
Participants are monitored for safety and effectiveness after treatment, including an End of Study visit
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Rifaximin 66mg + N-acetylcysteine 560mg
- RNIB21 containing rifaximin 132mg + N-acetylcysteine 560mg
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
RNIB21 containing rifaximin 66mg + NAC 560mg three times a day
RNIB21 containing rifaximin 132mg + NAC 560mg three times a day
placebo three times a day
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mark Pimentel, MD
Lead Sponsor
Citations
NCT06727422 | Efficacy of Rifaximin With NAC in IBS-D
The primary outcome for the study will be adequate relief of IBS symptoms based on FDA guidance during this period, specifically: the proportion of patients who ...
Trial | NCT06727422
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), ...
Effectiveness of Rifaximin on the Outcomes of Irritable Bowel ...
The results of our meta-analysis support the use of rifaximin in the treatment of IBS, owing to its safety and effectiveness.
Efficacy of Rifaximin With NAC in IBS-D - Carebox Connect
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 ...
RNIB21 in the Treatment of Irritable Bowel Syndrome with ...
The purpose of this study is to determine whether an investigational drug called RNIB21 can effectively relieve the symptoms of patients with irritable bowel ...
Low dose rifaximin combined with N-acetylcysteine is superior ...
These findings suggest that combining rifaximin with NAC may improve the percentage of IBS-D patients responding to treatment.
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