Methods and protocols
The Chemo-Gut Probiotic Trial Protocol: A Double-Blind Randomized Controlled Trial Investigating the Effects of a Multi-Strain Probiotic on Gut Microbiota, Gastrointestinal Symptoms, and Psychosocial Health Among Cancer Survivors
By Deleemans JM, Mina R, Spiropoulos A and 5 others.
Abstract
Background
Survivors of cancer experience chronic gastrointestinal (GI) and psychosocial health symptoms and reduced gut microbial diversity. This may compromise their long-term health and wellbeing. No studies have investigated probiotics for managing both GI and psychosocial symptoms together, or their effects on the composition of the gut microbiota in post-treatment cancer survivors.
Aims
To investigate the effects of a probiotic vs. placebo on (i) abdominal pain and depressive symptoms (primary outcomes); (ii) (a) GI (i.e., gas/bloating, diarrhea, and constipation), and psychosocial (i.e., anxiety, cognitive function, and fatigue) symptoms and (b) gut microbiota composition; and (iii) relationships between bacteria and GI and psychosocial symptoms.