Role of a Food Supplement Containing Curcumin, Green Tea and Vitamin D on Symptom Control in Diarrhoea Predominant Irritable Bowel Syndrome (IBS-D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Mean decrease of Irritable bowel syndrome symptom severity score (IBS-SSS)
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a highly prevalent condition of the gastrointestinal tract that has significant impact on sufferer's quality of life. The diarrhoea variant (IBS-D) makes up around one third of all IBS sufferers. There is currently a lack of both effective pharmacological and non-pharmacological treatments for IBS-D.
Three food supplements: Green tea, vitamin D and curcumin have all been shown to demonstrate benefit in either reducing symptoms in IBS or diarrhoea as individual ingredients, but have never been tested in combination to assess their effectiveness in IBS. This research study aims to examine the effectiveness of green tea, vitamin D and curcumin in combination compared to a placebo capsule in individual suffering from IBS-D.
The study will aim to enroll 78 participants with IBS-D and utilise a placebo-controlled double blind design. The study will consist of a 2 week screening period, a 4 week randomised treatment period (50% participants to receive placebo, 50% to receive active treatment), followed by a 4 week open label treatment period (all participants to receive the active study product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- •Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria.
- •Participant has an IBS-SSS score of >175 at screening.
- •Participant is a male or non-pregnant female and is ≥18 years of age
- •Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- •Participant has capacity to understand written English.
- •Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
- •Participant agrees to follow all pre-test preparation before breath testing visits.
排除标准
- •Prior abdominal surgery other than appendectomy and cholecystectomy.
- •Known hypercalcaemia.
- •Participating in another trial or taken an IMP within the last 1 month.
- •Females who report to be pregnant or lactating
- •Unwilling to maintain stable doses of permitted concomitant medication
- •Unwilling to maintain a stable diet for the duration of the trial
- •Being in the opinion of the investigator unsuitable
- •Insufficient knowledge of English to complete the daily bowel diary and food diary
- •Hypersensitivity to any component of the supplement
- •Hypersensitivity or known allergy to lactulose
- •Drug interactions with any component of the supplement
- •Consumption of antibiotics, prebiotics or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study.
- •Vitamin D two week washout
- •Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
- •Individuals declaring additional specific dietary needs
- •Inflammatory bowel disease or coeliac disease
- •Any other condition, deemed by the investigator, that may be causing their symptoms
- •No major co-morbidity.
- •Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
研究组 & 干预措施
Placebo
28 days placebo capsules 4x daily, followed by 28 days of open label active treatment
干预措施: Placebo Capsule(s) (Dietary Supplement)
Curcumin, Vitamin D and Green tea
28 days Curcumin, Vitamin D and Green tea capsules 4x daily, followed by a further 28 days of this treatment but non-blinded (open label)
干预措施: Curcumin, vitamin d and green tea extract (Dietary Supplement)
Curcumin, Vitamin D and Green tea
28 days Curcumin, Vitamin D and Green tea capsules 4x daily, followed by a further 28 days of this treatment but non-blinded (open label)
干预措施: Placebo Capsule(s) (Dietary Supplement)
结局指标
主要结局
Mean decrease of Irritable bowel syndrome symptom severity score (IBS-SSS)
时间窗: From Enrollment to end of 4 week randomised treatment period
Mean change in IBS-SSS at the end of the randomised treatment phase between Active and placebo arms. The IBS-SSS is numeric score based on 5 questions (each rated 0-100), with a total minimum score of 0 and maximum of 500, with a higher score indicating greater severity of symptoms.
次要结局
- Use of rescue medication(4 weeks)
- Assessment of change breath methane levels during hydrogen and methane breath testing (HMBT)(4 weeks)
- Mean change irritable bowel syndrome quality of life (IBS-QoL) questionnaire score(4 weeks)
- Longevity of treatment effect(8 weeks)
- Stool Consistency(4 weeks)
- Stool frequency(4 weeks)
- Change in bloating measured using daily bowel diary.(4 weeks)
- Change in abdominal pain measured using the daily bowel diary(4 weeks)
- Breath Hydrogen levels measured using hydrogen and methane breath testing (HMBT)(4 weeks)
研究者
Dr Anthony Hobson
Consultant Clinical Scientist
The Functional Gut Clinic