Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Epetôme on Gastrointestinal Function, Inflammation and Wellbeing in Adults With IBS-like Symptoms (EPEGUT) (EPEGUT)

29. oktober 2026 oppdatert av: ADELE COSTABILE, University of Roehampton

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Storbritannia
    • UK
      • London, UK, Storbritannia, SW15 4JD
        • University of Roehampton, School of Life and Health Sciences

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: (Epetōme® Synbiotic Dual Cap®)

A dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form.
Kosttilskudd: EPEGUT

a dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form.

Andre navn:
  • Active prebiotic (FOS) and probiotic ingredients.
Placebo komparator: Placebo comparator

Matching placebo comparator
Kosttilskudd: Placebo

Placebo comparator

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in gastrointestinal symptom severity
Tidsramme: baseline, week 4 and week 12

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in digestive comfort
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes Health-related quality of life
Tidsramme: 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
Perceived stress
Tidsramme: 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
General wellbeing
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Roehampton

Etterforskere

  • Studieleder: Adele Costabile, Prof, School of Life and Health Sciences University of Roehampton | London | SW15 4JD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

15. januar 2027

Studiet fullført (Antatt)

20. september 2027

Datoer for studieregistrering

Først innsendt

19. oktober 2026

Først innsendt som oppfylte QC-kriteriene

29. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EPEGUT Study

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere