Visbiome Effect on Colorectal Anastomosis and Local Recurrence

July 12, 2021 updated by: Russell Farmer, University of Louisville
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.
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
Time Frame: Every three months for 1 year post hospital discharge.
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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