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 : February 26, 2019

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Drug: Rifaximin Drug: Placebo	Phase 3

Study Design

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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 2020
Estimated Study Completion Date :	April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Drug Information available for: Rifaximin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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: 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.
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.	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: 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.

Arm

Intervention/treatment

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.

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:

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.

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.

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:

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.

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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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
Memorial Sloan Kettering Cancer Center Sleepy Hollow
Sleepy Hollow, New York, United States, 10591

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

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Principal Investigator:	Philip Paty, MD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center This link exits the ClinicalTrials.gov site

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Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01345175 History of Changes
Other Study ID Numbers:	11-045
First Posted:	April 29, 2011 Key Record Dates
Last Update Posted:	February 26, 2019
Last Verified:	February 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:


rectal colon PLACEBO	RIFAXIMIN metronidazole 11-045

Additional relevant MeSH terms:

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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

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