Prevention of Irinotecan Induced Diarrhea by Probiotics

PHASE3CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

January 31, 2014

Conditions
Colorectal Cancer
Interventions
DIETARY_SUPPLEMENT

Probiotic formula

Probiotic formula Colon DophilusTM , will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.

DIETARY_SUPPLEMENT

Placebo

Placebo capsules will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.

Trial Locations (6)

81250

Oncologic Institute of St.Elisabeth OUSA, Bratislava

91101

Faculty Hospital Trencin, Trenčín

94501

Zdravspol s r.o. - oncologic ambulance, Komárno

085 01

St.James Hospital and Clinic, Bardejov

833 10

National Cancer Institute, Slovakia, Bratislava

058 01

POKO Poprad Ltd., Poprad

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Harmonium International Inc.

INDUSTRY

collaborator

Pharma Agency

UNKNOWN

lead

Monsea Ltd.

INDUSTRY

NCT01410955 - Prevention of Irinotecan Induced Diarrhea by Probiotics | Biotech Hunter | Biotech Hunter