Loading clinical trials...

Visbiome Effect on Colorectal Anastomosis and Local Recurrence | Clinical Trials | Clareo Health

WITHDRAWNNA

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

NCT03524638•University of Louisville

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Key Dates

Start Date

April 13, 2018

Primary Completion Date

July 29, 2019

Completion Date

July 29, 2019

Last Updated

July 16, 2021

Conditions

Colorectal Cancer

Interventions

Visbiome

OTHER

Colorectal Surgery

PROCEDURE

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors