Sharma 2013.

Trial name or title	A phase II/III, randomised, double‐blind, placebo‐controlled study to investigate the efficacy of a probiotic VSL#3 on chemotherapy‐induced diarrhea in people with cancer receiving fluoropyrimidines and/or irinotecan (interim analysis) Clinical Trial Registry number: CTRI/2009/091/001042
Methods	Randomised, parallel‐group, placebo‐controlled trial Country: India
Participants	Participants ≥ 18 years with histologically confirmed diagnosis of cancer, treated with fluoropyrimodines and/or irinotecan‐based chemotherapy; ECOG ≤ 2 Participants with recurrent disease must have completed last chemotherapy 4 weeks before enrolment in the study
Interventions	VSL#3 sachets; 1 sachet bid for 12 to 16 weeks. Each sachet contains 900 billion CFU Placebo sachets; 1 sachet bid for 16 weeks
Outcomes	Primary outcome: incidence and duration of grade 3 and 4 diarrhoea caused by fluoropyrimidines and/or irinotecan Secondary outcomes: Reduction in use of rescue medications (loperamide, antibiotics for diarrhoea) Weight loss Frequency of use of TPN (total parenteral nutrition) Frequency of use of IV fluids Incidence and duration of all grades of diarrhoea Assessment of health‐related quality of life Incidence of oral mucositis Incidence of grade III or IV neutropenia Stool consistency (Bristol Stool Chart) Chemotherapy dose modification Chemotherapy treatment delays Time points: at all chemotherapy cycles, that is, cycles 1, 2, and 3 of chemotherapy and at the follow‐up visit (i.e. 2 weeks after third cycle of chemotherapy)
Starting date	27/7/2010
Contact information	Dr Atul Sharma; atul1@hotmail.com
Notes	Conference abstract (limited reporting of interim analysis without unblinding)