Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation
NCT01839721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246
Last updated 2013-05-17
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.
Conditions
- Cancer
- Diarrhea
- Abdominal Pain
- Quality of Life
Interventions
- DRUG
-
Bifilact®
placebo, standard dose 1.3 billion twice a day, high dose 10 billion three time a day
- OTHER
-
placebo
Sponsors & Collaborators
-
CHU de Quebec-Universite Laval
lead OTHER
Principal Investigators
-
Dagnault Anne, PhD · CHU de Quebec
-
Josee Desjardins, B.Sc, RD · Chu de Quebec
-
Mimi Demers, B.Sc. RD · CHU de Québec
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2010-11-30
- Completion
- 2010-12-31
Countries
- Canada
Study Locations
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