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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：ADELE COSTABILE, Prof
- 电话号码：3571 02083923571
- 邮箱：adele.costabile@roehampton.ac.uk
研究联系人备份
- 姓名：Savriniso Nazarova-Lewis
- 电话号码：02083923571
- 邮箱：s.nazarova-lewis@roehampton.ac.uk
学习地点
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UK
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London、UK、英国、SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：(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.
其他名称：
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安慰剂比较：Placebo comparator
Matching placebo comparator |
Placebo comparator |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in gastrointestinal symptom severity
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in digestive comfort
大体时间：Baseline, week 4 and week 12
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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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes Health-related quality of life
大体时间：Baseline, week 4 and week 12
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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
大体时间：Baseline, week 4 and week 12
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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
大体时间：Baseline, week 4 and week 12
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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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合作者和调查者
调查人员
- 研究主任：Adele Costabile, Prof、School of Life and Health Sciences University of Roehampton | London | SW15 4JD
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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