Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT07253155

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionGut Inflammation, Overweight and Obese Volunteers

Full registry criteria

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%)

Treatments and study arms

Probiotic Arm

Dietary Supplement

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

Placebo Arm

Dietary Supplement

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

Primary outcomes

Assess effects of FX856 on faecal calprotectinChange over 28 days comparison between treatments

The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ulster University, Human Intervention Studies Unit🇬🇧 Coleraine, United Kingdom

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