An interventional study of Probiotic Arm and Placebo Arm in Gut Inflammation and Overweight and Obese Volunteers, sponsored by University of Ulster. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by University of Ulster · Not applicable, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probiotic supplement arm, 2 capsules consumed/day for a period of 28 days.
Dietary Supplement: Probiotic Arm
Placebo supplement arm, 2 capsules consumed/day for a period of 28 days.
Dietary Supplement: Placebo Arm
1 x10\^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.
corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.
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.
Time frame: Change over 28 days comparison between treatments
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)
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IFN-γ
Measured by ELISA
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-1β
Measured by ELISA
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-6
Measured by ELISA
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines TNF-α
Measured by ELISA
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change over 28 days comparison between treatments
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Ulster