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

Status:	Active, not recruiting
Conditions:	Colorectal Cancer, Cancer, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Oncology
Healthy:	No
Age Range:	21 - Any
Updated:	2/28/2019
Start Date:	April 2011
End Date:	April 2020

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

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.

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.

We found this trial at

sites

Memorial Sloan-Kettering Cancer Center - Basking Ridge

136 Mountainview Blvd
Basking Ridge, New Jersey 7920

(908) 542-3000