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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07253155
Enrollment
100
Registered
2025-11-28
Start date
2025-10-14
Completion date
2028-09-01
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Inflammation, Overweight and Obese Volunteers

Keywords

Obesity, gut inflammation, gastrointestinal symptoms, microbiota, metabolome, overweight

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTProbiotic Arm

1 x10\^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule.

DIETARY_SUPPLEMENTPlacebo Arm

corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule.

Sponsors

Ferryx Limited
CollaboratorUNKNOWN
University of Ulster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double blinded to participants and researchers

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Either a BMI 25+ kg/m2 and be aged 40+ years or have a BMI 30+ kg/m2 and aged 18+ years * Males and females (not currently pregnant/lactating) * Omnivorous diet (consuming plant & animal based foods) * Not taking any medication affecting the gastro-intestinal tract * No chronic gastro-intestinal illness * Not using fibre supplements or any probiotic or prebiotic products, e.g., Fybogel, Actimel, kefir or kimchee for at least 6 weeks prior to study * Not consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \ 12%)

Exclusion criteria

* Not aged 40+ years (if have a BMI 25-29.9 kg/m2) * BMI\<30 kg/m2 (if aged 18-39 years) * Pregnant/lactating female * Vegan/vegetarian/high protein diet * Chronic gastro-intestinal illness * Taking medication affecting the gastro-intestinal tract * Taking fibre supplements or any probiotic or prebiotic products * Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \ 12%)

Design outcomes

Primary

MeasureTime frameDescription
Assess effects of FX856 on faecal calprotectinChange over 28 days comparison between treatmentsThe level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.

Secondary

MeasureTime frameDescription
Assess effects of FX856 on blood metabolomeChange over 28 days comparison between treatmentsThe 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.
Assess effect of FX856 treatment on gastrointestinal symptomsChange over 28 days comparison between treatmentsMeasured by questionnaire rated on scale from 0 (Dose not bother me at all) to 10 (Is as bad as I can imagine)
Assess effect of FX856 on circulating inflammatory cytokines IFN-γChange over 28 days comparison between treatmentsMeasured by ELISA
Assess effect of FX856 on circulating inflammatory cytokines IL-1βChange over 28 days comparison between treatmentsMeasured by ELISA
Assess effect of FX856 on circulating inflammatory cytokines IL-6Change over 28 days comparison between treatmentsMeasured by ELISA
Assess effects of FX856 on faecal metabolomeChange over 28 days comparison between treatmentsThe 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.
Assess effect of FX856 on CholesterolChange over 28 days comparison between treatmentsMeasured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.
Assess effect of FX856 on LDL cholesterolChange over 28 days comparison between treatmentsMeasured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. LDL concentrations calculated using the Friedewald formula.
Assess effect of FX856 on HDL cholesterolChange over 28 days comparison between treatmentsMeasured via ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.
Assess effects of FX856 on microbiotaChange over 28 days comparison between treatmentsThe 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.
Assess effect of FX856 on circulating inflammatory cytokines TNF-αChange over 28 days comparison between treatmentsMeasured by ELISA

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026