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Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Sponsor
University of Louisville (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03524638
Collaborator
(none)
0
Enrollment
2
Arms
15.5
Actual Duration (Months)

Study Details

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
  • Other: Visbiome
  • Procedure: Colorectal Surgery
 N/A

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
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 :
Apr 13, 2018
Actual Primary Completion Date :
Jul 29, 2019
Actual Study Completion Date :
Jul 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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • University of Louisville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jul 16, 2021