Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Study Overview
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Brief Summary
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Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence

Detailed Description
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Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.

Official Title
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Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Visbiome
* Procedure: Colorectal Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM A<br>Colorectal surgery with administration of Visbiome | Other: Visbiome<br>* Colorectal surgery plus administration of Visbiome on post-operative day 2.<br>Procedure: Colorectal Surgery<br>* Colorectal surgery alone<br>|
| Active Comparator: ARM B<br>Colorectal Surgery alone | Procedure: Colorectal Surgery<br>* Colorectal surgery alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Anastomotic Leak | Development of anastomotic leak will be evaluated by sigmoidoscopy | Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year. | 
| Local Recurrence | CT scans will be performed every 3 months after hospital discharge to check disease status | Every three months for 1 year post hospital discharge. |