Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Other: Visbiome; Procedure: Colorectal Surgery

• Registration Number: NCT03524638
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2018-04-13
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-15
• Primary Completion: 2019-07-29
• Study Completion: 2019-07-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A	Colorectal Surgery	Colorectal surgery with administration of Visbiome
ARM A	Visbiome	Colorectal surgery with administration of Visbiome
ARM B	Colorectal Surgery	Colorectal Surgery alone

Primary Outcome Measures

Name	Time	Method
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