Trial Outcomes & Findings for Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease (NCT NCT01137955)
NCT ID: NCT01137955
Last Updated: 2022-06-29
Results Overview
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
COMPLETED
NA
50 participants
Baseline (week 0)
2022-06-29
Participant Flow
Recruited from Celiac Disease Center.
Fifty participants were enrolled and 41 participants completed the trial.
Participant milestones
| Measure |
Rifaximin
Antibiotic ( 25 subjects)
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
Inert capsules ( 25 Subjects)
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Rifaximin
Antibiotic ( 25 subjects)
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
Inert capsules ( 25 Subjects)
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
Baseline characteristics by cohort
| Measure |
Rifaximin
n=25 Participants
Antibiotic ( 25 subjects) 400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
n=25 Participants
Inert capsules ( 25 Subjects) Placebo capsules 3 times a day for 10 days.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 14.6 • n=93 Participants
|
43.4 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0)Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Outcome measures
| Measure |
Rifaximin
n=20 Participants
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
n=21 Participants
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
|
2.7 Score on a scale
Standard Deviation 1.1
|
2.8 Score on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Week 2Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Outcome measures
| Measure |
Rifaximin
n=20 Participants
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
n=21 Participants
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score
|
2.3 score on a scale
Standard Deviation 0.6
|
2.4 score on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Week 12Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Outcome measures
| Measure |
Rifaximin
n=20 Participants
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
n=21 Participants
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score
|
2.5 score on a scale
Standard Deviation 0.8
|
2.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 12 weeksA breath test measures for small intestine bacterial overgrowth (SIBO). The breath test measures the amount of hydrogen exhaled after drinking a sugar (lactulose) solution. An abnormal breath test is defined as: 1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 minutes, or 2) two peaks ≥20 ppm over baseline.
Outcome measures
| Measure |
Rifaximin
n=20 Participants
400 mg capsules of Rifaximin 3 times a day for 10 days.
|
Placebo
n=21 Participants
Placebo capsules 3 times a day for 10 days.
|
|---|---|---|
|
Percentage of Participants With Abnormal Breath Test
|
12 Percent of Participants
|
20 Percent of Participants
|
Adverse Events
Rifaximin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter Green
Celiac Disease Center at Columbia University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place