Trial · NCT01137955
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
NCT01137955, Not applicable, Completed, Columbia University; results first posted 2022-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease. Trials, record NCT01137955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
- NCT number
- NCT01137955
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Celiac Disease
- Interventions
- Rifaximin, Placebo
- First posted
- 2010-06-07
- Last updated
- 2022-06-29
- Results first posted
- 2022-06-29
- Limitations and caveats
- Small sample size. Challenges of diagnosing bacterial overgrowth.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | 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. |
| Primary | Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Week 2 | 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. |
| Primary | Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Week 12 | 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. |
| Secondary | Percentage of Participants With Abnormal Breath Test | Up to 12 weeks | A 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | Baseline (week 0) | Score on a scale | MEAN | |
| PRIMARY | Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Week 2 | score on a scale | MEAN | |
| SECONDARY | Percentage of Participants With Abnormal Breath Test | Up to 12 weeks | Percent of Participants | NUMBER | |
| PRIMARY | Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Week 12 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | Rifaximin | 2.7 | Standard Deviation 1.1 | Score on a scale | |
| Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score | Placebo | 2.8 | Standard Deviation 0.9 | Score on a scale | |
| Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Rifaximin 400mg | 2.3 | Standard Deviation 0.6 | score on a scale | |
| Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score | Placebo | 2.4 | Standard Deviation 0.6 | score on a scale | |
| Percentage of Participants With Abnormal Breath Test | Rifaximin | 12 | Percent of Participants | ||
| Percentage of Participants With Abnormal Breath Test | Placebo | 20 | Percent of Participants | ||
| Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Rifaximin 400mg | 2.5 | Standard Deviation 0.8 | score on a scale | |
| Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score | Placebo | 2.5 | Standard Deviation 0.8 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rifaximin | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Rifaximin | 20 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Rifaximin | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rifaximin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rifaximin | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 21 |
| Total, serious adverse events | Rifaximin | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21647654 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rifaximin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01137955
GET https://conductscience.org/api/trials/v1/NCT01137955/registered