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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: ADELE COSTABILE, Prof
- 전화번호: 3571 02083923571
- 이메일: adele.costabile@roehampton.ac.uk
연구 연락처 백업
- 이름: Savriniso Nazarova-Lewis
- 전화번호: 02083923571
- 이메일: s.nazarova-lewis@roehampton.ac.uk
연구 장소
-
-
UK
-
London, UK, 영국, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: (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.
다른 이름들:
|
|
위약 비교기: Placebo comparator
Matching placebo comparator |
Placebo comparator |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in gastrointestinal symptom severity
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in digestive comfort
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes Health-related quality of life
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Adele Costabile, Prof, School of Life and Health Sciences University of Roehampton | London | SW15 4JD
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- EPEGUT Study
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .