NCT02819960.

Trial name or title	Prevention of irinotecan‐induced diarrhea by probiotics
Methods	Allocation: randomised Intervention model: parallel assignment Masking: double‐blind (participant, care provider) Primary purpose: prevention
Participants	Estimated enrolment: 100 Ages eligible for study: ≥ 18 years (adult, senior) Genders eligible for study: female Accepts healthy volunteers: no Inclusion criteria: Signed written informed consent Age > 18 years Patients with histologically proven colorectal cancer starting new line of chemotherapy based on irinotecan ECOG PS 0 or 1 at study entry Life expectancy > 3 months Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow‐up schedule Exclusion criteria: Not possible to take oral medication Active infection treated by antibiotic therapy Ileostoma Hypersensitivity to study drug Any concurrent malignancy other than non‐melanoma skin cancer, no other cancer in past 5 years Serious concomitant systemic disorder or disease incompatible with the study (at the discretion of the investigator)
Interventions	Probiotic group: probiotic formula PROBIO‐FIX INUM will be administered at a dose of 3 × 1 cps per day orally for 6 weeks. No premedication or patient monitoring after administration of probiotic formula is required. Probiotic formula may be taken after meals or snacks to reduce stomach upset. Swallow the capsule, or in case of problems with swallowing, capsule can be opened and content mixed with small amount of food. Food must not be hot Placebo group: maltodextrin will be used for placebo group and will be administered at a the same dose as active formula (3 × 1 cps per day orally for 6 weeks)
Outcomes	Primary outcome measures: Prevention of grade 3 or 4 diarrhoea induced by irinotecan‐based chemotherapy [Time Frame: first 6 weeks of irinotecan‐based chemotherapy] To determine efficacy (as measured by prevention of grade 3/4 diarrhoea) of probiotic formula PROBIO‐FIX INUM given orally to patients with colorectal cancer starting new line of irinotecan‐based chemotherapy. Response will be defined as prevention of grade 3/4 diarrhoea according to definition of NCI CTC version 4.0 Secondary outcome measures: Progression‐free survival [Time Frame: 1 year] Progression‐free survival period will be evaluated according to standard protocol Prevention of diarrhoea of any grade [Time Frame: 6 weeks] To determine the efficacy (as measured by prevention of grade 1/2 diarrhoea) of probiotic formula PROBIO‐FIX INUM given orally to patients with colorectal cancer during first 6 weeks of irinotecan‐based chemotherapy. Response will be defined as prevention of grade 1/2 diarrhoea according to definition of NCI CTC version 4.0 Prevention of other gastrointestinal symptoms [Time Frame: 6 weeks] To determine the efficacy (as measured by prevention of enterocolitis) of probiotic formula PROBIO‐FIX INUM given orally to patients with colorectal cancer starting new line of irinotecan‐based chemotherapy. Response will be defined as prevention of enterocolitis during first 6 weeks of irinotecan‐based chemotherapy according to definition of NCI CTC version 4.0 Incidence of treatment‐emergent adverse events [Safety and Toxicity] [Time Frame: 6 weeks] Safety and toxicity will be evaluated according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) (see Appendix D; http://www.fda.gov/cder/cancer/toxicityframe.htm)
Starting date	ClinicalTrials.gov Identifier: NCT02819960 Study start date: March 2016 Estimated primary completion date: March 2018 (final data collection date for primary outcome measure)
Contact information	Contact: Michal Mego, MD misomego@gmail.com
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