Clinical trial · Interventional
Visbiome Effect on Colorectal Anastomosis and Local Recurrence
NCT03524638CI-TRIAL-00052740withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator decided to withdraw the study.
Summary
Brief summary (as posted)
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colorectal Surgery | Procedure | — | UNRESOLVED |
| Visbiome | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A
- description
- Colorectal surgery with administration of Visbiome
- interventionNames
- Other: Visbiome
- Procedure: Colorectal Surgery
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- Colorectal Surgery alone
- interventionNames
- Procedure: Colorectal Surgery
Primary outcomes (2)
- measure
- Development of Anastomotic Leak
- timeFrame
- Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.