Visbiome Effect on Colorectal Anastomosis and Local Recurrence

• ClinicalTrials.gov Identifier: NCT03524638
• Recruitment Status: Withdrawn
• First Posted: May 15, 2018
• Last Update Posted: July 16, 2021
• Sponsor: University of Louisville
• Information provided by (Responsible Party): Russell Farmer, University of Louisville

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Other: Visbiome; Procedure: Colorectal Surgery	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Visbiome Effect on Colorectal Anastomosis and Local Recurrence
• Actual Study Start Date: April 13, 2018
• Actual Primary Completion Date: July 29, 2019
• Actual Study Completion Date: July 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Russell Farmer, Principal Investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT03524638
• Other Study ID Numbers: 18-0282
• First Posted: May 15, 2018
• Last Update Posted: July 16, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Recurrence; Disease Attributes; Pathologic Processes