Probiotics and Recovery From Surgery
Phase 3
Terminated
- Conditions
- Major Abdominal Operation
- Interventions
- Dietary Supplement: VSL #3 BID
- Registration Number
- NCT01970683
- Lead Sponsor
- Catholic Health Initiatives
- Brief Summary
The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.
- Detailed Description
Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- All elective major GI surgical patients
Exclusion Criteria
-
• Current episode of acute pancreatitis as defined by clinician
- Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo VSL #3 BID Near-identically appearing placebo VSL #3 VSL #3 BID probiotics given orally BID
- Primary Outcome Measures
Name Time Method 30-day postsurgical outcome including death, infection, readmission within 30 days after surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mercy Medical Center-Des Moines
🇺🇸Des Moines, Iowa, United States