Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Colorectal Cancer Clinical Trial

Official title:

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03524638
• Other study ID #: 18-0282
• Status: Withdrawn
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: July 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Recurrence

Intervention

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

Procedure:
• Colorectal Surgery
Colorectal surgery alone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.