Probiotics and Recovery From Gastrointestinal Surgery - 2 (PROGRESS-2)

Jan Franko, MD

Status and phase: Unknown; Phase 3

Conditions: Surgical Recovery

Treatments: Drug: SuperBio probiotic; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04266106

MMC-2019-56

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Treatment:

Drug: Placebo

probiotic

Experimental group

Treatment:

Drug: SuperBio probiotic