Visbiome Effect on Colorectal Anastomosis and Local Recur... | NCT03524638

Studies
Visbiome Effect on Colorectal Anastomosis and Local Recurrence

NCT03524638

Sponsor

University of Louisville

Status

Withdrawn

Last Update Posted

Jul 16, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

Visbiome
Colorectal Surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator decided to withdraw the study.

Expanded Access Info

Start Date

Apr 13, 2018Actual

Primary Completion Date

Jul 29, 2019Actual

Completion Date

Jul 29, 2019Actual

First Submitted Date

May 2, 2018

First Submission Date that Met QC Criteria

May 2, 2018

First Posted Date

May 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2021

Last Update Posted Date

Jul 16, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Visbiome	Other	Colorectal surgery plus administration of Visbiome on post-operative day 2.	ARM A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site