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

Last updated: April 19, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Completed

Phase

3

Condition

Colon Cancer

Colorectal Cancer

Rectal Cancer

Treatment

Placebo

Rifaximin

Clinical Study ID

NCT01345175
11-045
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a history of rectal cancer treated with an anterior resectionpreformed at MSKCC (tumor at or below 12cm from anal verge) with restoration ofbowel continuity ≥1 and ≤ 5 years. (Patients may also have had procedures toconstruct 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 symptomsmay include any of the following: incomplete evacuation, clustering of bowelmotions, frequency of bowel motions, unformed stool, excessive flatus, orincontinence of flatus and/or feces.

Exclusion

Exclusion Criteria:

  • Local recurrence of rectal cancer.

  • Antibiotic treatment within the last 4 weeks for any condition.

  • Pregnancy or breast feeding.

Study Design

Total Participants: 69
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 26, 2011
Estimated Completion Date:
March 23, 2023

Connect with a study center

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Commack

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Sleepy Hollow

    Sleepy Hollow, New York 10591
    United States

    Site Not Available

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