Effects of Epetôme on Gastrointestinal Function, Inflammation and Wellbeing in Adults With IBS-like Symptoms (EPEGUT) (EPEGUT)
EPEGUT: Effects of Epetôme Supplementation on Gastrointestinal Function, Inflammatory Biomarkers and Wellbeing in Adults With IBS-like Symptoms
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
In this context, Epetome is a food supplement containing fructo-oligosaccharides (FOS) and a combined probiotic formulation, designed to support gastrointestinal and overall gut health through a targeted nutritional approach. By combining the potential benefits associated with prebiotic and probiotic strategies, Epetome aims to support the gut microbial ecosystem and its interaction with the host. This may be particularly relevant for individuals experiencing persistent IBS-like gastrointestinal symptoms, where alterations in microbial composition and function may contribute to digestive discomfort and impaired wellbeing.This study will test whether 12 weeks of daily Epetome supplementation, compared with a matched placebo, improves gastrointestinal function, inflammatory biomarkers and wellbeing in adults aged 35-50 years with IBS-like gastrointestinal symptoms.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: ADELE COSTABILE, Prof
- Telefonnummer: 3571 02083923571
- E-Mail: adele.costabile@roehampton.ac.uk
Studieren Sie die Kontaktsicherung
- Name: Savriniso Nazarova-Lewis
- Telefonnummer: 02083923571
- E-Mail: s.nazarova-lewis@roehampton.ac.uk
Studienorte
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UK
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London, UK, Vereinigtes Königreich, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: (Epetōme® Synbiotic Dual Cap®)
A dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form. |
a dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form.
Andere Namen:
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Placebo-Komparator: Placebo comparator
Matching placebo comparator |
Placebo comparator |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in gastrointestinal symptom severity
Zeitfenster: baseline, week 4 and week 12
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Change from baseline to Week 12 in gastrointestinal symptom severity, assessed using the Gastrointestinal Symptom Rating Scale (GSRS) total score, comparing participants receiving Epetōme® Synbiotic Dual Cap® with those receiving placebo. The outcome will be measured as the mean change in GSRS total score from baseline to Week 12, with higher scores indicating greater symptom severity. |
baseline, week 4 and week 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in digestive comfort
Zeitfenster: Baseline, week 4 and week 12
|
Change from baseline to Week 12 in gastrointestinal symptom severity and digestive comfort, assessed using a validated gastrointestinal symptom questionnaire. Outcomes will be compared between participants receiving Epetōme® Synbiotic Dual Cap® and those receiving placebo. |
Baseline, week 4 and week 12
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes Health-related quality of life
Zeitfenster: Baseline, week 4 and week 12
|
Change from baseline to Week 12 in health-related quality of life, assessed using the EQ-5D-5L questionnaire or another specified validated quality-of-life instrument. Changes in the relevant total or domain-specific scores will be compared between the intervention and placebo groups. |
Baseline, week 4 and week 12
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Perceived stress
Zeitfenster: Baseline, week 4 and week 12
|
Change from baseline to Week 12 in perceived stress, assessed using the 10-item Perceived Stress Scale (PSS-10). Changes in total scores will be compared between participants receiving Epetōme® Synbiotic Dual Cap® and those receiving placebo. |
Baseline, week 4 and week 12
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General wellbeing
Zeitfenster: Baseline, week 4 and week 12
|
Change from baseline to Week 12 in general psychological wellbeing, assessed using the WHO-5 Well-Being Index. Changes in total wellbeing scores will be compared between the intervention and placebo groups. |
Baseline, week 4 and week 12
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Adele Costabile, Prof, School of Life and Health Sciences University of Roehampton | London | SW15 4JD
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EPEGUT Study
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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