Probiotics and Recovery From Surgery (PROGRESS)

Catholic Health Initiatives

Status and phase: Terminated; Phase 3

Conditions: Major Abdominal Operation

Treatments: Dietary Supplement: VSL #3 BID

Study type: Interventional

Funder types: Other

Identifiers

NCT01970683

MMC-2013-132

Details and patient eligibility

About

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

Full description

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

VSL #3

Experimental group

Description:

probiotics given orally BID

Treatment:

Dietary Supplement: VSL #3 BID

placebo

Other group

Description:

Near-identically appearing placebo

Treatment:

Dietary Supplement: VSL #3 BID