Probiotics and Recovery From Surgery

Phase 3TerminatedNCT01970683

Catholic Health Initiatives140 enrolled

Overview

The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.

Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

140

Conditions

Major Abdominal Operation

Interventions

VSL #3 BIDDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mercy Medical Center-Des Moines

Des Moines, Iowa, United States

Outcomes

Primary Outcomes

30-day postsurgical outcome including death, infection, readmission

Time frame: within 30 days after surgery

Data from ClinicalTrials.gov

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