IBS - Irritable Bowel SyndromeEPEGUTNCT07916948
Effects of Epetôme on Gastrointestinal Function, Inflammation and Wellbeing in Adults With IBS-like Symptoms (EPEGUT)
A study testing EPEGUT in people with IBS - Irritable Bowel Syndrome and Gastrointestinal Motility Disorder, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Gastrointestinal Motility Disorder
- What is being tested?
- EPEGUT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2026to 20 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Roehampton, School of Life and Health Sciences
London, UK, SW15 4JD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- EPEGUT, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPEGUTDietary supplement
Also called Active prebiotic (FOS) and probiotic ingredients.
a dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form.
PlaceboDietary supplement
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| (Epetōme® Synbiotic Dual Cap®) | Active comparator | A dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form. Receives: Dietary Supplement: EPEGUT |
| Placebo comparator | Placebo comparator | Matching placebo comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastrointestinal symptom severity
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.
Measured: baseline, week 4 and week 12
Secondary outcomes (1)
Changes in digestive comfort
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.
Measured: Baseline, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week randomized, double-blind, placebo-controlled, parallel-group dietary intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADELE COSTABILE, University of Roehampton
- Investigators
- Adele Costabile, Prof, Study director, School of Life and Health Sciences University of Roehampton | London | SW15 4JD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916948
- Sponsor's protocol ID
- EPEGUT Study
- Acronym
- EPEGUT
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPEGUT: Effects of Epetôme Supplementation on Gastrointestinal Function, Inflammatory Biomarkers and Wellbeing in Adults With IBS-like Symptoms
- ClinicalTrials.gov ID
- NCT07916948
- Acronym / sponsor ID
- EPEGUT / EPEGUT Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 12-week randomized, double-blind, placebo-controlled, parallel-group dietary intervention
| Arm | Type | Receives |
|---|---|---|
| (Epetōme® Synbiotic Dual Cap®) | Active comparator | Dietary Supplement: EPEGUTA dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form. |
| Placebo comparator | Placebo comparator | Dietary Supplement: PlaceboMatching placebo comparator |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPEGUTAlso: Active prebiotic (FOS) and probiotic ingredients.a dietary supplement containing fructooligosaccharides (FOS), a prebiotic fibre, combined with probiotic microorganisms in capsule form. | Dietary supplement | (Epetōme® Synbiotic Dual Cap®) |
| PlaceboPlacebo comparator | Dietary supplement | Placebo comparator |
Primary outcome
Changes in gastrointestinal symptom severity
Time frame: 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.
1 secondary outcome
Changes in digestive comfort
Time frame: Baseline, week 4 and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adele Costabile, Prof study director
School of Life and Health Sciences University of Roehampton | London | SW15 4JD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPEGUT in people with IBS - Irritable Bowel Syndrome and Gastrointestinal Motility Disorder, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savriniso Nazarova-Lewis (02083923571, s.nazarova-lewis@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gastrointestinal symptom severity (time frame: baseline, week 4 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.