Phase 1 clinical trial evaluating whether probiotic supplementation prevents chemotherapy-induced diarrhoea and other intestinal adverse effects in cancer patients.

Intervention:
MultiBiotic probiotic formulation containing per capsule:
Lactobacillus rhamnosus (Med 26)9 billion CFU
Lactobacillus acidophilus (Med 27)3.75 billion CFU
Lactobacillus plantarum (Med 25)1.575 billion CFU
Bifidobacterium animalis spp. lactis (Med 13)3 billion CFU
Bifidobacterium breve (Med 12)1.75 billion CFU
Bifidobacterium bifidum (Med 11)500 million CFU
Streptococcus thermophilus (Med 51)1.5 billion CFU
Total21.075 Billion CFU* / 1 capsule
Dosage: 2 capsules twice daily.
Mode of administration: oral
Duration of intervention: 12 weeks
Monitoring: Drug bottles returned (empty or not) to trial investigator.
Primary outcome(s): A composite primary outcome of physical, social, emotional and functional well-being (33 items) will be evaluated according to the FACT-C scale.
The primary outcome will be the mean change in the FACT C total score (33-item) between baseline and end of of the study (12 weeks). [Participants Research Diary collected at the end of the study (12 weeks)];Mean change in Bristol Stool scores between baseline and end of the study (12 weeks).[Participants Research Diary collected at the end of the study (12 weeks)];Mean changes in blood lipopolysaccharide between baseline and end of three chemotherapy cycles.[Blood drawn at baseline and the end of the study (12 weeks).]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy