Trial · NCT01345175
Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
NCT01345175, Phase 3, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2024-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer. Trials, record NCT01345175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01345175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
- NCT number
- NCT01345175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Rectal Cancer
- Interventions
- Rifaximin, Placebo
- First posted
- 2011-04-29
- Last updated
- 2024-05-14
- Results first posted
- 2024-05-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | 1 year | |
| Secondary | To Determine if Reduction in Intestinal Bacterial Quantity Correlates With Improvement in Bowel Symptoms (BFI Score). | 1 year | |
| Secondary | To Explore the Bacterial Composition of Stool Before and After Antibiotic Treatment. | 1 year | |
| Secondary | To Identify Dynamic Changes in Bowel Function During and After Antibiotic Treatment Using a Bowel Function Log. | 1 year | |
| Secondary | Efficacy of Metronidazole | 1 year | in the treatment of bowel dysfunction as measured by the MSKCC BFI in patients following AR or SPS for rectal cancer for patients who have no improvement following treatment with rifaximin or placebo. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Determine if Reduction in Intestinal Bacterial Quantity Correlates With Improvement in Bowel Symptoms (BFI Score). | 1 year | N/A Data were not collected | ||
| SECONDARY | To Explore the Bacterial Composition of Stool Before and After Antibiotic Treatment. | 1 year | N/A Data were not collected | ||
| SECONDARY | To Identify Dynamic Changes in Bowel Function During and After Antibiotic Treatment Using a Bowel Function Log. | 1 year | N/A data were not completed | ||
| SECONDARY | Efficacy of Metronidazole | 1 year | N/A Data were not collected |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | Pts Receiving Rifaximin | Completed BFI | 30 | Participants | |
| Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | Pts Receiving Placebo | Completed BFI | 27 | Participants | |
| Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | Pts Receiving Rifaximin | Did not complete BFI | 6 | Participants | |
| Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer. | Pts Receiving Placebo | Did not complete BFI | 6 | Participants |
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 | Pts Receiving Rifaximin | 36 | |
| Overall Study | STARTED | Pts Receiving Placebo | 33 | |
| Overall Study | COMPLETED | Pts Receiving Rifaximin | 30 | |
| Overall Study | COMPLETED | Pts Receiving Placebo | 27 | |
| Overall Study | NOT COMPLETED | Pts Receiving Rifaximin | 6 | |
| Overall Study | NOT COMPLETED | Pts Receiving Placebo | 6 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Diarrhea | Gastrointestinal disorders | Arm 1: Experimental: Pts Receiving Rifaximin | 0 | 36 | |
| serious | Diarrhea | Gastrointestinal disorders | Arm 2: Placebo Comparator: Pts Receiving Placebo | 1 | 33 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Experimental: Pts Receiving Rifaximin | 0 | 36 |
| Total, all-cause mortality | Arm 2: Placebo Comparator: Pts Receiving Placebo | 0 | 33 |
| Total, other adverse events | Arm 1: Experimental: Pts Receiving Rifaximin | 0 | 36 |
| Total, other adverse events | Arm 2: Placebo Comparator: Pts Receiving Placebo | 0 | 33 |
| Total, serious adverse events | Arm 1: Experimental: Pts Receiving Rifaximin | 0 | 36 |
| Total, serious adverse events | Arm 2: Placebo Comparator: Pts Receiving Placebo | 1 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1: Experimental: Pts Receiving Rifaximin vs Arm 2: Placebo Comparator: Pts Receiving Placebo: deaths from any cause | Trial comparisons |
| Arm 1: Experimental: Pts Receiving Rifaximin vs Arm 2: Placebo Comparator: Pts Receiving Placebo: serious adverse events | 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/NCT01345175
GET https://conductscience.org/api/trials/v1/NCT01345175/registered