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Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Rifaximin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Philip Paty, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

Official title: Randomized Control Trial Comparing Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To determine if reduction in intestinal bacterial quantity correlates with improvement in bowel symptoms (BFI score).

To explore the bacterial composition of stool before and after antibiotic treatment.

To identify dynamic changes in bowel function during and after antibiotic treatment using a bowel function log.

efficacy of metronidazole

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center Commack, Commack, New York 11725, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

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

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: April 2011
Last updated: March 24, 2015

Page last updated: August 23, 2015

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