Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04557215 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of Rifaximin With NAC in IBS-D
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT04557215: Completed Phase 1 study, sponsored by Cedars-Sinai Medical Center.
NCT04557215 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04557215, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Randomized, prospective proof of concept, double-blind, single site clinical trial to determine the efficacy of combined rifaximin and N-acetylcysteine (NAC) therapy vs. rifaximin alone in decreasing clinical symptoms in subjects with IBS-D.
Primary Outcome
Change in stool form from baseline, as determined from stool diary data comparing Rifaximin alone vs rifaximin and NAC The Bristol Stool Chart, the minimum value is 1 (means constipation) and maximum value is 7 (means diarrhea). The change between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)
Interventions
- DRUG Placebo
- DRUG Rifaximin
- DRUG N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2022-10-30 |
| Phase | Phase 1 |
What the finished NCT04557215 record still lists
NCT04557215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04557215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04557215 about?
NCT04557215 is a clinical study titled "Efficacy and Safety of Rifaximin With NAC in IBS-D". Randomized, prospective proof of concept, double-blind, single site clinical trial to determine the efficacy of combined rifaximin and N-acetylcysteine (NAC) therapy vs. rifaximin alone in decreasing clinical symptoms in subjects with IBS-D.
What is the current status of trial NCT04557215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2020-11-13. Estimated completion is 2022-10-30.
What interventions are being tested in trial NCT04557215?
The interventions under investigation include: Placebo (DRUG), Rifaximin (DRUG), N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT04557215?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04557215's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI