Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
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ClinicalTrials.gov Identifier: NCT01345175 |
Recruitment Status :
Active, not recruiting
First Posted : April 29, 2011
Last Update Posted : May 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Rectal Cancer | Drug: Rifaximin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Control Trial Comparing Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2023 |

Arm | Intervention/treatment |
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Experimental: Pts receiving Rifaximin
This group will receive rifaximin 400mg bid for 4 weeks. At 1 - 24 months after completion of the phase III portion of the trial, patients will be contacted by phone and given the option of receiving metronidazole in a followup, single arm study in which all patients receive the antibiotic. Patients who wish to participate will be mailed a drug prescription for a 3 week course of metronidazole 500mgs tid as well as the BFI forms and stool diary. Pretreatment and post treatment BFI scores will be collected and analyzed for change in bowel function as was done in the initial Phase III study.
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Drug: Rifaximin
Pt will receive rifaximin 400mg bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.
Other Names:
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Placebo Comparator: Pts receiving placebo
This group will receive a placebo bid for 4 weeks. At 1 - 24 months after completion of the phase III portion of the trial, patients will be contacted by phone and given the option of receiving metronidazole in a followup, single arm study in which all patients receive the antibiotic. Patients who wish to participate will be mailed a drug prescription for a 3 week course of metronidazole 500mgs tid as well as the BFI forms and stool diary. Pretreatment and post treatment BFI scores will be collected and analyzed for change in bowel function as was done in the initial Phase III study.
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Drug: Placebo
Pt will receive placebo bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.
Other Names:
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- To compare the efficacy of rifaximin and placebo in the treatment of bowel dysfunction as measured by MSKCC Bowel Function Instrument (BFI score) in patients following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for rectal cancer. [ Time Frame: 1 year ]
- To determine if reduction in intestinal bacterial quantity correlates with improvement in bowel symptoms (BFI score). [ Time Frame: 1 year ]
- To explore the bacterial composition of stool before and after antibiotic treatment. [ Time Frame: 1 year ]
- To identify dynamic changes in bowel function during and after antibiotic treatment using a bowel function log. [ Time Frame: 1 year ]
- efficacy of metronidazole [ Time Frame: 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.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a history of rectal cancer treated with an anterior resection preformed at MSKCC (tumor at or below 12cm from anal verge) with restoration of bowel continuity ≥1 and ≤ 5 years. (Patients may also have had procedures to construct neo-rectums including j-pouch, coloplasty, and end to side anastomosis).
- Patients ≥ 21 years of age.
- Presence of anterior resection symptoms by patients own assessment. These symptoms may include any of the following: incomplete evacuation, clustering of bowel motions, frequency of bowel motions, unformed stool, excessive flatus, or incontinence of flatus and/or feces.
Exclusion Criteria:
- Local recurrence of rectal cancer.
- Antibiotic treatment within the last 4 weeks for any condition.
- Pregnancy or breast feeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345175
United States, New Jersey | |
Memorial Sloan Kettering Cancer Center at Basking Ridge | |
Basking Ridge, New Jersey, United States | |
United States, New York | |
Memorial Sloan Kettering Cancer Center Commack | |
Commack, New York, United States, 11725 | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Philip Paty, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01345175 |
Other Study ID Numbers: |
11-045 |
First Posted: | April 29, 2011 Key Record Dates |
Last Update Posted: | May 3, 2022 |
Last Verified: | May 2022 |
rectal colon PLACEBO |
RIFAXIMIN metronidazole 11-045 |
Rectal Neoplasms Intestinal Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Rectal Diseases Anti-Bacterial Agents Metronidazole Rifaximin Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Antiprotozoal Agents Antiparasitic Agents Gastrointestinal Agents |