← Back to Search

Antibiotic

Rifaximin for Colorectal Cancer

Phase 3

Waitlist Available

Led By Philip Paty, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will compare the antibiotic rifaximin to a placebo in the treatment of bowel problems after rectal surgery. If successful, the antibiotic metronidazole will also be tested.

Eligible Conditions

Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

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.

+1 more

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581

19%

Hepatic encephalopathy

17%

Oedema peripheral

16%

Constipation

14%

Nausea

14%

Fatigue

12%

Insomnia

11%

Urinary tract infection

10%

Pruritus generalised

Muscle spasms

Abdominal pain

Decreased appetite

Ascites

Dyspnoea

Headache

Cough

Renal failure acute

Vomiting

Asthenia

Anaemia

Anxiety

Jaundice

Diarrhoea

Abdominal distension

Cellulitis

Depression

Bronchitis

Peritonitis bacterial

Hyperkalaemia

Liver transplant

Gastrointestinal haemorrhage

Acute respiratory failure

Haematemesis

Hyperglycaemia

Fluid overload

Non-cardiac chest pain

Herpes zoster

Cerebrovascular accident

Thrombocytopenia

Pneumococcal bacteraemia

Pneumonia

Sepsis

Septic shock

Craniocerebral injury

Hepatic failure

Hepatitis

Hepatorenal syndrome

Toxic encephalopathy

Subarachnoid haemorrhage

Anxiety disorder

Suicidal ideation

Calculus ureteric

Oliguria

Renal failure

Pleural effusion

Flatulence

Cardiac failure congestive

Haematochezia

Upper gastrointestinal haemorrhage

Chest pain

Systemic inflammatory response syndrome

Chronic hepatic failure

Subdural haematoma

Dehydration

Alcoholic seizure

Hypovolaemic shock

100%

80%

60%

40%

20%

Study treatment Arm

Rifaximin 550 mg BID

Rifaximin 550 mg BID + Lactulose

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pts receiving RifaximinExperimental Treatment1 Intervention

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.

Group II: Pts receiving placeboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rifaximin

2005

Completed Phase 4

~3120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,828 Total Patients Enrolled

Philip Paty, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

726 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being recruited for this research project?

"There is no longer any need for participants in this trial, according to the information found on clinicaltrials.gov. This research project was originally posted on 4/1/2011 and had its last update on 5/2/2022. There are presently 594 other studies that are actively recruiting patients."

Answered by AI

Has Rifaximin been cleared by the FDA?

"There is some efficacy data and numerous rounds of safety testing, so Rifaximin was given a score of 3 by our team."

Answered by AI

What medical conditions does Rifaximin usually treat?

"Rifaximin is the standard medication used to treat disinfection. However, it can also be used to manage other medical conditions such as trichomonas infections, dermatitis, and postoperative infection prevention."

Answered by AI

Are there any other case studies that feature Rifaximin?

"Rifaximin was first studied in 2009 at New mexico VA Healthcare System. Since the initial study, there have been a total of 18619 completed clinical trials. Out of these, 109 are actively recruiting patients right now; many of these studies taking place out of Basking Ridge, New jersey."

Answered by AI

How many people are subjects in this clinical trial?

"Unfortunately, this clinical trial is no longer enrolling patients. The original posting was on April 1st, 2011 and the last update was on May 2nd, 2022. However, there are presently 485 trials actively admitting patients with intestinal diseases and 109 trials for Rifaximin actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2011. "Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01345175.