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Probiotic supplement for gut symptoms in people with overweight or obesity

Tests a probiotic against placebo for gut inflammation in adults with overweight or obesity.

Plain-language title generated from the registry record
Registry title: Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.

Key facts

Where
Coleraine, United KingdomSee the site

Where in United Kingdom

  • Ulster University, Human Intervention Studies UnitColeraine, United KingdomNo longer taking part

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
University of Ulster
Trial code
NCT07253155
Record updated
28 November 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Taking medication affecting the gastro-intestinal tract; Chronic gastro-intestinal illness; 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; Taking fibre supplements or any probiotic or prebiotic products; Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine ~12%).

ClinicalTrials.gov NCT07253155