Visbiome Effect on Colorectal Anastomosis and Local Recurrence

NCT03524638 | Withdrawn

• 1 other identifier: 18-0282
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

ARM A

ACTIVE COMPARATOR

Colorectal surgery with administration of Visbiome

Other: Visbiome; Procedure: Colorectal Surgery

ARM B

ACTIVE COMPARATOR

Colorectal Surgery alone

Procedure: Colorectal Surgery

Interventions

Visbiome OTHER

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

ARM A

Colorectal Surgery PROCEDURE

Colorectal surgery alone

ARM A; ARM B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: April 13, 2018
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share