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NCT07916948
Effects of Epetôme on Gastrointestinal Function, Inflammation and Wellbeing in Adults With IBS-like Symptoms (EPEGUT)
Conditions: IBS - Irritable Bowel Syndrome, Gastrointestinal Motility Disorder
Sex: All
Ages: 35 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: University of Roehampton
Location: University of Roehampton, School of Life and Health Sciences London UK
Summary
Irritable bowel syndrome (IBS) is a common functional gastrointestinal condition characterised by symptoms including abdominal pain or discomfort, bloating, altered bowel habits and changes in digestive comfort. These symptoms can substantially affect quality of life, dietary behaviour, social functioning, and overall wellbeing. Although the underlying mechanisms are complex and multifactorial, growing evidence indicates that the gut microbiota and its interactions with the intestinal environment, immune system, gastrointestinal function, and gut-brain axis may play an important role in gastrointestinal health and symptom development. Prebiotics and probiotics have received increasing attention as nutritional strategies for supporting gut health. Prebiotics are substrates selectively utilised by beneficial microorganisms in the gut and can promote microbial growth and metabolic activity, including the production of short-chain fatty acids that contribute to intestinal barrier function, immune regulation, and colonic health. Probiotics are live microorganisms that, when administered in adequate amounts, may provide health benefits to the host. Selected probiotic strains have been investigated for their potential to support microbial balance, intestinal function, digestive comfort, and immune and inflammatory responses. However, responses to individual prebiotic or probiotic interventions can vary considerably between individuals, highlighting the potential value of complementary or combined nutritional approaches.
Eligibility Criteria
Inclusion Criteria:
* Healthy adults, aged 35-50, with self-reported, persistent IBS-like gastrointestinal symptoms (e.g., abdominal pain or discomfort, bloating, altered bowel habits) at screening
* Generally healthy, with no serious long-term medical conditions
* Living in the UK
* Able to read English and provide electronic informed consent
* Willing and able to comply with study procedures, including dietary intervention and sample collection
* Willing to provide stool, first-spot urine, saliva and blood samples at specified time points
* No intentional dieting within the past month
* Willing to keep their usual diet and not start other probiotic, prebiotic or fibre supplements during the study
Exclusion Criteria:
* Formal diagnosis of IBS or any other gastrointestinal disease
* Immunocompromised status or other serious chronic illness
* Use of antibiotics within the past 3 months
* Regular use of probiotics or prebiotics within the past 4 weeks
* Use of medications or special diets that significantly affect gut microbiota (e.g., chronic laxatives, immunosuppressants)
* Known allergies or intolerances to components of the study products (Epetome or placebo)
* Participation in another interventional clinical trial within the past 3 months
Source: ClinicalTrials.gov (NCT07916948). StuddyBuddy aggregates publicly available trial information.