Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval

Criteria

Inclusion Criteria:

• They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1

Exclusion Criteria:

• they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance