Probiotics and Recovery From Gastrointestinal Surgery - 2
Phase 3
- Conditions
- Surgical Recovery
- Interventions
- Drug: PlaceboDrug: SuperBio probiotic
- Registration Number
- NCT04266106
- Lead Sponsor
- Jan Franko, MD
- Brief Summary
This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Adults aged ≥18 years undergoing elective major abdominal operation
- Functional GI tract expected after operation
Exclusion Criteria
- Current episode of acute necrotizing pancreatitis as defined by surgeon
- Palliative decompressive GI tube
- Life expectancy ≤ 6 months
- Systemic immune-mediated disease active requiring systemic therapy:
- Prednisone ≥20 mg QD
- IV immunoglobulins
- Anti-rejection medication
- Presence of functional transplanted organ
- Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
- Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
- Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
- Need for full systemic anticoagulation postoperatively.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Comparator Placebo - probiotic SuperBio probiotic -
- Primary Outcome Measures
Name Time Method Quality of Life up to 2 months Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MercyOne Des Moines Medical Center
🇺🇸Des Moines, Iowa, United States