Surgical Recovery
Conditions
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.
Interventions
DRUGSuperBio probiotic
One capsule po BID for 28 days
DRUGPlacebo
One capsule po BID for 28 days
Sponsors
SuperBio
Jan Franko, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactJan Franko
Outcome results
None listed