A Phase 3 interventional study of Rifaximin and Placebo in Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. In order to test this idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. Following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. Both Metronidazole and rifaximin are well established drugs that have minimal side effects.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 69 is close to the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Exclusion Criteria:
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.
Drug: Rifaximin
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.
Drug: Placebo
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.
Also known as: 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, posttreatment BFI scores will be collected and analyzed for change in bowel function as, was done in the initial Phase III study.
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.
Also known as: 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.
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.
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
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.
Time frame: 1 year
| Milestone | Pts Receiving Rifaximin | Pts Receiving Placebo |
|---|---|---|
| Started | 36 | 33 |
| Completed | 30 | 27 |
| Not completed | 6 | 6 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Failed to complete bfi | 3 | 2 |
| Withdrew: Stopped taking medication | 2 | 2 |
| Participants | Pts Receiving Rifaximin | Pts Receiving Placebo |
|---|---|---|
| Completed BFI | 30 | 27 |
| Did not complete BFI | 6 | 6 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Experimental: Pts Receiving Rifaximin | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Arm 2: Placebo Comparator: Pts Receiving Placebo | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) |
| Event | Arm 1: Experimental: Pts Receiving Rifaximin | Arm 2: Placebo Comparator: Pts Receiving Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 0/36 | 1/33 |
| Age, Continuous(years) | Pts Receiving Rifaximin | Pts Receiving Placebo | Total |
|---|---|---|---|
| Mean | 55.47 ± 8.87 | 61.09 ± 10.51 | 58.16 ± 9.69 |
| Sex: Female, Male(Participants) | Pts Receiving Rifaximin | Pts Receiving Placebo | Total |
|---|---|---|---|
| Female | 17 | 20 | 37 |
| Male | 19 | 13 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Pts Receiving Rifaximin | Pts Receiving Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 4 |
| Not Hispanic or Latino | 32 | 30 | 62 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Pts Receiving Rifaximin | Pts Receiving Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 33 | 31 | 64 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Pts Receiving Rifaximin | Pts Receiving Placebo | Total |
|---|---|---|---|
| United States | 36 | 33 | 69 |
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Memorial Sloan Kettering Cancer Center