Trial Outcomes & Findings for Efficacy and Safety of Rifaximin With NAC in IBS-D (NCT NCT04557215)
NCT ID: NCT04557215
Last Updated: 2023-03-28
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
value at 6 weeks minus value at baseline
Results posted on
2023-03-28
Participant Flow
Participant milestones
| Measure |
Standard Dose for IBS-D
Rifaximin 550 mg
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Traveler's Diarrhea Dose + Placebo
Rifaximin 200 mg + placebo
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Traveler's Diarrhea Dose + NAC
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Rifaximin With NAC in IBS-D
Baseline characteristics by cohort
| Measure |
Standard Dose for IBS-D
n=15 Participants
Rifaximin 550 mg
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Traveler's Diarrhea Dose + Placebo
n=15 Participants
Rifaximin 200 mg + placebo
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Traveler's Diarrhea Dose + NAC
n=15 Participants
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 17 • n=5 Participants
|
44 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 13 • n=5 Participants
|
45.89 years
STANDARD_DEVIATION 15.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: value at 6 weeks minus value at baselineChange 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)
Outcome measures
| Measure |
Rifaximin 550 mg
n=15 Participants
Rifaximin 550 mg Standard dose for IBS-D
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Rifaximin 200 mg + Placebo
n=15 Participants
Rifaximin 200 mg + placebo Traveler's diarrhea dose + placebo
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days
n=15 Participants
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days Traveler's diarrhea dose + NAC
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
|---|---|---|---|
|
Change in Stool Form
|
-0.26 score on a scale
Standard Deviation 0.69
|
-0.45 score on a scale
Standard Deviation 0.86
|
-0.49 score on a scale
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: value at 6 weeks minus value at baselineChange in severity of abdominal pain from baseline, as determined from weekly average visual analog scale (VAS) scores, relative to Rifaximin alone. VAS scores allows subject to choose 0 for "no pain" to 100 "pain as bad as it could possibly be". The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 "no pain" and 100 "pain as bad as it could possibly be" The change between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)
Outcome measures
| Measure |
Rifaximin 550 mg
n=15 Participants
Rifaximin 550 mg Standard dose for IBS-D
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Rifaximin 200 mg + Placebo
n=15 Participants
Rifaximin 200 mg + placebo Traveler's diarrhea dose + placebo
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days
n=15 Participants
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days Traveler's diarrhea dose + NAC
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
|---|---|---|---|
|
Change in Abdominal Pain
|
-5.43 units on a scale
Standard Deviation 13.91
|
-8.90 units on a scale
Standard Deviation 21.42
|
-5.59 units on a scale
Standard Deviation 15.99
|
PRIMARY outcome
Timeframe: value at 6 weeks minus value at baselineChange in stool frequency from baseline, as determined from diary data comparing Rifaximin alone vs Rifaximin and NAC determined from daily stool diary data The change in bowel movements/day between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)
Outcome measures
| Measure |
Rifaximin 550 mg
n=15 Participants
Rifaximin 550 mg Standard dose for IBS-D
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Rifaximin 200 mg + Placebo
n=15 Participants
Rifaximin 200 mg + placebo Traveler's diarrhea dose + placebo
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days
n=15 Participants
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days Traveler's diarrhea dose + NAC
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
|---|---|---|---|
|
Change in Stool Frequency
|
-0.04 number of bowel movements
Standard Deviation 0.64
|
-0.50 number of bowel movements
Standard Deviation 1.50
|
-0.24 number of bowel movements
Standard Deviation 0.80
|
Adverse Events
Rifaximin 550 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Rifaximin 200 mg + Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rifaximin 550 mg
n=15 participants at risk
Rifaximin 550 mg (Standard dose for IBS-D)
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
|
Rifaximin 200 mg + Placebo
n=15 participants at risk
Rifaximin 200 mg + placebo (Traveler's diarrhea dose + placebo)
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
|
Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days
n=15 participants at risk
Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days (Traveler's diarrhea dose + NAC)
Rifaximin: Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
N-acetylcysteine: N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
|
|---|---|---|---|
|
Gastrointestinal disorders
Bloating & Constipation
|
6.7%
1/15 • Number of events 1 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/15 • 6 weeks
|
6.7%
1/15 • Number of events 1 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
|
Gastrointestinal disorders
Headache and nausea
|
0.00%
0/15 • 6 weeks
|
6.7%
1/15 • Number of events 1 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
|
Gastrointestinal disorders
Burning in esophagus
|
0.00%
0/15 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
6.7%
1/15 • Number of events 1 • 6 weeks
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/15 • 6 weeks
|
0.00%
0/15 • 6 weeks
|
6.7%
1/15 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place