Probiotics and Recovery From Gastrointestinal Surgery - 2

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Surgical Recovery

In brief

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.

Key facts

Study ID

NCT04266106

Run by

Jan Franko, MD

People needed

300

Starts

2020-02-01

Expected to finish

2021-10-01

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged ≥18 years undergoing elective major abdominal operation
• Functional GI tract expected after operation

You may not qualify if…

• 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.

Where it is running

• MercyOne Des Moines Medical Center — Des Moines, Iowa, United States

Full record on ClinicalTrials.gov

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