Colorectal Cancer
Conditions
Brief summary
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence
Detailed description
Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.
Interventions
OTHERVisbiome
Colorectal surgery plus administration of Visbiome on post-operative day 2.
PROCEDUREColorectal Surgery
Colorectal surgery alone
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Diagnosis of biopsy proven rectal cancer (CT/MRI) * Willing and able to comply with protocol requirements * Able to tolerate surgery * Able to comprehend and have signed the Informed Consent * Absence of metastatic disease * Clinical performance status of ECOG 0 or 1 * Life expectancy of greater than 3 months * Planned ileostomy as part of their routine care
Exclusion criteria
* Severe or refractory ulcerative colitis defined as Mayo Score of greater than or equal to 10, endoscopic disease activity score 3 * Untreated enteric infection (positive stool test for any of the following: clostridium difficile, salmonella, shigella, yersinia, campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the Investigator * Severe immunodeficiency, inherited or required (e.g. HIV, chemotherapy or radiation therapy) * Patients with the following laboratory abnormalities: absolute neutrophil count \<1000/ul, platelets \<50 x 10\^9/L, hemoglobin \<6.5g/dL * History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish) * Active intestinal obstruction * Non-steroidal anti inflammatory medications (NSAIDs) as long-term treatment, defined as for at least 4 days per week each month * Cholestyramine use * Any condition in which the Investigator thinks VSL3 administration may pose a health risk (e.g. severely immunocompromised) * Simultaneous participation in another interventional clinical trial * Patients who are pregnant, breast feeding or planning pregnancy during study trial period * Patients with any other signification medical condition that could confound or interfere with evaluation of safety, tolerability or prevention compliance with the study protocol at the discretion of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Anastomotic Leak | Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year. | Development of anastomotic leak will be evaluated by sigmoidoscopy |
| Local Recurrence | Every three months for 1 year post hospital discharge. | CT scans will be performed every 3 months after hospital discharge to check disease status |
Outcome results
None listed