Visbiome Effect on Colorectal Anastomosis and Local Recurrence

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

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Visbiome; Procedure: Colorectal Surgery

Detailed Description

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): July 29, 2019

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 18-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No