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Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Primary Purpose

Colorectal Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Visbiome

Colorectal Surgery

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ARM A

ARM B

Arm Description

Colorectal surgery with administration of Visbiome

Colorectal Surgery alone

Outcomes

Primary Outcome Measures

Development of Anastomotic Leak

Development of anastomotic leak will be evaluated by sigmoidoscopy

Local Recurrence

CT scans will be performed every 3 months after hospital discharge to check disease status

Secondary Outcome Measures

Full Information

NCT ID

NCT03524638

First Posted

May 2, 2018

Last Updated

July 12, 2021

Sponsor

University of Louisville

1. Study Identification

Unique Protocol Identification Number

NCT03524638

Brief Title

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Official Title

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator decided to withdraw the study.

Study Start Date

April 13, 2018 (Actual)

Primary Completion Date

July 29, 2019 (Actual)

Study Completion Date

July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM A

Arm Type

Active Comparator

Arm Description

Colorectal surgery with administration of Visbiome

Arm Title

ARM B

Arm Type

Active Comparator

Arm Description

Colorectal Surgery alone

Intervention Type

Other

Intervention Name(s)

Visbiome

Intervention Description

Colorectal surgery plus administration of Visbiome on post-operative day 2.

Intervention Type

Procedure

Intervention Name(s)

Colorectal Surgery

Intervention Description

Colorectal surgery alone

Primary Outcome Measure Information:

Title

Development of Anastomotic Leak

Description

Development of anastomotic leak will be evaluated by sigmoidoscopy

Time Frame

Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.

Title

Local Recurrence

Description

CT scans will be performed every 3 months after hospital discharge to check disease status

Time Frame

Every three months for 1 year post hospital discharge.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

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