NCT01579591

VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer

A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in Increasing the Pathological Major Response Rate in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
OTHER	VSL#3	1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
OTHER	Placebo	1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-04-18
• Last updated: 2012-04-18

Locations

1 site across 1 country: Italy