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| Name | Class |
|---|---|
| Ferryx Limited | UNKNOWN |
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Inflammatory bowel disease (IBD) affects over 6.8 million people worldwide, with current treatments often causing side effects and poor patient compliance. Dysbiosis of gut microbiota is a key factor, and while probiotics are considered safe and beneficial, conventional strains fail to function effectively during active inflammation due to high iron levels in the gut. Streptococcus thermophilus (FX856), unlike traditional probiotics, can thrive in this iron-rich environment, promoting mucosal healing. A 2-way crossover intervention study will be conducted with FX856 supplementation in overweight and obese individuals who often exhibit mild gut inflammation by measuring faecal calprotectin and systemic inflammatory markers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Arm | Experimental | Probiotic supplement arm, 2 capsules consumed/day for a period of 28 days. |
|
| Placebo Arm | Placebo Comparator | Placebo supplement arm, 2 capsules consumed/day for a period of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Arm | Dietary Supplement | 1 x10^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess effects of FX856 on faecal calprotectin | The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it. | Change over 28 days comparison between treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Assess effect of FX856 treatment on gastrointestinal symptoms | Measured by questionnaire rated on scale from 0 (Dose not bother me at all) to 10 (Is as bad as I can imagine) | Change over 28 days comparison between treatments |
| Assess effect of FX856 on circulating inflammatory cytokines IFN-γ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Gill, PhD | Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulster University, Human Intervention Studies Unit | Coleraine | BT52 1SA | United Kingdom |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Double blinded to participants and researchers
| Placebo Arm | Dietary Supplement | corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule. |
|
Measured by ELISA |
| Change over 28 days comparison between treatments |
| Assess effect of FX856 on circulating inflammatory cytokines IL-1β | Measured by ELISA | Change over 28 days comparison between treatments |
| Assess effect of FX856 on circulating inflammatory cytokines IL-6 | Measured by ELISA | Change over 28 days comparison between treatments |
| Assess effect of FX856 on circulating inflammatory cytokines TNF-α | Measured by ELISA | Change over 28 days comparison between treatments |
| Assess effect of FX856 on Cholesterol | Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. | Change over 28 days comparison between treatments |
| Assess effect of FX856 on LDL cholesterol | Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. LDL concentrations calculated using the Friedewald formula. | Change over 28 days comparison between treatments |
| Assess effect of FX856 on HDL cholesterol | Measured via ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. | Change over 28 days comparison between treatments |
| Assess effects of FX856 on microbiota | The composition of gut microbiota from faecal samples will be measured by NGS pre and post consumption in all participants to determine if FX856 consumption alters the gut microbiota. | Change over 28 days comparison between treatments |
| Assess effects of FX856 on faecal metabolome | The faecal metabolome from faecal samples will be measured by untargeted mass spec pre and post consumption in all participants to determine if FX856 consumption alters the faecal metabolome. | Change over 28 days comparison between treatments |
| Assess effects of FX856 on blood metabolome | The blood metabolome will be measured by untargeted mass spec pre and post consumption in all participants to determine if FX856 consumption alters the blood metabolome. | Change over 28 days comparison between treatments |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |