Colorectal CancerNCT03524638
Visbiome Effect on Colorectal Anastomosis and Local Recurrence
A study testing Visbiome and Colorectal Surgery in people with Colorectal Cancer, run by University of Louisville.
Trial summary
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Visbiome and Colorectal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2018to 29 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Clinical performance status of ECOG 0 or 1
- Life expectancy of greater than 3 months
- Planned ileostomy as part of their routine care
Who cannot join
- 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
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- 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
About this study
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence
Read the detailed description
Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.
- Conditions
- Colorectal Cancer
- Being tested
- Visbiome, Colorectal Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisbiomeOther
Colorectal surgery plus administration of Visbiome on post-operative day 2.
Colorectal SurgeryProcedure or surgery
Colorectal surgery alone
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Active comparator | Colorectal surgery with administration of Visbiome Receives: Other: Visbiome; Procedure: Colorectal Surgery |
| ARM B | Active comparator | Colorectal Surgery alone Receives: Procedure: Colorectal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Anastomotic Leak
Development of anastomotic leak will be evaluated by sigmoidoscopy
Measured: 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
Measured: Every three months for 1 year post hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start13 Apr 2018
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Why it stopped: Investigator decided to withdraw the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Farmer, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524638
- Sponsor's protocol ID
- 18-0282
- Status last verified
- Jul 2021
- First submitted
- 2 May 2018
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visbiome Effect on Colorectal Anastomosis and Local Recurrence
- ClinicalTrials.gov ID
- NCT03524638
- Acronym / sponsor ID
- 18-0282
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided to withdraw the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence
Detailed description
Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Active comparator | Other: Visbiome, Procedure: Colorectal SurgeryColorectal surgery with administration of Visbiome |
| ARM B | Active comparator | Procedure: Colorectal SurgeryColorectal Surgery alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisbiomeColorectal surgery plus administration of Visbiome on post-operative day 2. | Other | ARM A |
| Colorectal SurgeryColorectal surgery alone | Procedure or surgery | ARM A, ARM B |
Primary outcome
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Visbiome and Colorectal Surgery in people with Colorectal Cancer, run by University of Louisville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Anastomotic Leak (time frame: Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.