Visbiome Effect on Colorectal Anastomosis and Local Recurrence

NCT ID: NCT03524638

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2019-07-29

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ARM A

Colorectal surgery with administration of Visbiome

Group Type: ACTIVE_COMPARATOR

Visbiome

Intervention Type: OTHER

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

Colorectal Surgery

Intervention Type: PROCEDURE

Colorectal surgery alone

ARM B

Colorectal Surgery alone

Group Type: ACTIVE_COMPARATOR

Colorectal Surgery

Intervention Type: PROCEDURE

Colorectal surgery alone

Interventions

Visbiome

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

Intervention Type: OTHER

Colorectal Surgery

Colorectal surgery alone

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Russell Farmer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

18-0282

Identifier Type: -

Identifier Source: org_study_id