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ENROLLING BY INVITATION
NCT07253155
NA

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

Sponsor: University of Ulster

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10-14

Completion Date

2028-09-01

Last Updated

2025-11-28

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Probiotic Arm

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

DIETARY_SUPPLEMENT

Placebo Arm

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

Locations (1)

Ulster University, Human Intervention Studies Unit

Coleraine, United Kingdom