Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.

There is a lack of satisfactory treatments for inflammatory bowel disease (IBD), an excruciatingly debilitating condition which affects 1 in 123 people in the UK (\>0.5million). Current treatments have significant negative side effects, affecting quality of life of patients and reducing compliance, leading to exacerbation of symptoms. Dysbiosis in the composition of gut microbiota is one of the leading causes of chronic inflammatory diseases such as inflammatory bowel disease (IBD). Supplementation with dietary components is a promising approach for the treatment of inflammatory bowel disease (IBD) and the use of probiotics for IBD treatment has shown promising effects on consumers' quality of life, they are popular due to their perception as safe, natural treatments but currently marketed products cannot function during active disease. Streptococcus thermophilus (FX856) is an OTC supplement already available in the UK that has a unique ability to survive and thrive during active inflammation, allowing it to promote mucosal healing in the inflamed gut, an area where conventional probiotics have failed. During active inflammation or stress, gut iron levels increase. This iron-rich environment compromises the suitability of conventional probiotic bacteria that have been, and are still, commonly trailed for the relief of symptoms in patients suffering from gut inflammation. Whilst most constituents of the gut microbiome are able to increase growth rate in response to iron, species traditionally employed as probiotics, such as lactobacilli and bifidobacteria, are unable to use iron as a growth factor; they are outcompeted under high iron conditions and cannot have a beneficial effect. Unlike most bacterial strains used as probiotics, FX856 can maintain growth within an iron-rich environment, as observed in the inflamed intestine. Faecal calprotectin is considered a suitable non-invasive surrogate marker of intestinal inflammation in inflammatory bowel disease and is reported to be increased in obese individuals. Consequently, this study will determine how the probiotic FX856 interacts with the gut and immune system to reduce inflammation. A 2-way crossover intervention study will be conducted with FX856 (4 weeks) in an overweight and obese population, as such individuals are likely to have chronic mild gut inflammation and examine markers of faecal calprotectin and circulating inflammatory markers.

• Assess effect of FX856 treatment on gastrointestinal symptoms [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on circulating inflammatory cytokines IFN-γ [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on circulating inflammatory cytokines IL-1β [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on circulating inflammatory cytokines IL-6 [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on circulating inflammatory cytokines TNF-α [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on Cholesterol [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on LDL cholesterol [Time frame: Change over 28 days comparison between treatments]
• Assess effect of FX856 on HDL cholesterol [Time frame: Change over 28 days comparison between treatments]
• Assess effects of FX856 on microbiota [Time frame: Change over 28 days comparison between treatments]
• Assess effects of FX856 on faecal metabolome [Time frame: Change over 28 days comparison between treatments]
• Assess effects of FX856 on blood metabolome [Time frame: Change over 28 days comparison between treatments]